Stapling systems and methods for surgical devices and end effectors

ABSTRACT

An end effector includes an anvil and a cartridge. The anvil can include a plurality of staple pockets positioned on an anvil face. The cartridge can be configured to retain a plurality of staples. Each of the plurality of staples includes a first staple leg, a second staple leg, and a crown connecting the first staple leg and the second staple leg, and each has an open staple configuration where the first staple leg and the second staple leg are generally perpendicular to a longitudinal axis of the crown and a closed staple configuration where a first tip of the first staple leg is bent in a first direction away from the longitudinal axis of the crown, and a second tip of the second staple leg is bent in a second direction away from the longitudinal axis of the crown, the first direction being different than the second direction.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/126,604, filed Sep. 10, 2018, which is a continuation of U.S. patentapplication Ser. No. 16/103,644, filed Aug. 14, 2018, which claims thepriority benefit of: U.S. Provisional Patent Application No. 62/676,493,filed May 25, 2018; U.S. Provisional Patent Application No. 62/672,996,filed May 17, 2018; U.S. Provisional Patent Application No. 62/662,517,filed Apr. 25, 2018; U.S. Provisional Patent Application No. 62/579,703,filed Oct. 31, 2017; and U.S. Provisional Patent Application No.62/545,324, filed Aug. 14, 2017, each of which is hereby incorporatedherein by reference in its entirety.

TECHNICAL FIELD

Embodiments of the technology relate, in general, to surgical staplingtechnology, and in particular to end effectors and stapling devices andmethods of using those devices in surgical procedures.

SUMMARY

Embodiments include an end effector for use by a surgeon to staple ananatomical structure of a patient, the end effector including a firstjaw having a first end, a second end, a longitudinal axis, and an anvilhaving an anvil face; a second jaw having a first end, a second end, alongitudinal axis, and a cartridge operably configured to house aplurality of staples, the cartridge having a cartridge face; a firstcoupling that couples the first end of the first jaw to the first end ofthe second jaw; and a second coupling that movably couples the secondend of the first jaw to the second end of the second jaw, where thesecond coupling includes a rigid link connected to the first jaw and thesecond jaw.

In certain embodiments, the first end of the first jaw is a distal endof the first jaw and the second end of the first jaw is a proximal endof the first jaw. In certain embodiments, the first coupling comprises apin having a pin axis, the pin axis being transverse to the longitudinalaxis of the first jaw and the longitudinal axis of the second jaw,wherein the pin pivotally couples the first end of the first jaw to thefirst end of the second jaw. In certain embodiments, the second couplingcomprises a slot defined by the first jaw or the second jaw that retainsthe rigid link such that the rigid link is slidable within the slot. Incertain embodiments, the slot has a length of from 3 millimeters to 8millimeters. Certain embodiments include a plurality of staples at leastpartially retained by the cartridge of the second jaw. In certainembodiments, the plurality of staples retained at least partially by thecartridge are positioned between the first coupling and the secondcoupling. Certain embodiments include a blade having a cutting surfaceand at least one lateral arm. Certain embodiments include a channeldefined by the first jaw or the second jaw to retain the at least onelateral arm of the blade. In certain embodiments, the blade istransitioned from a first position at a distal end of the end effectorto a second position at a proximal end of the end effector such that theanatomical structure is resected.

Embodiments of a method of stapling an anatomical structure of a patientduring a minimally invasive procedure, the anatomical structure having afirst side and a second side, include the steps of providing an endeffector including a first jaw having a first end, a second end, alongitudinal axis, and an anvil, the anvil having an anvil face; asecond jaw having a first end, a second end, a longitudinal axis, and acartridge retaining a plurality of staples, the cartridge having acartridge face; a first coupling that couples the first end of the firstjaw to the first end of the second jaw; a second coupling that movablycouples the second end of the first jaw to the second end of the secondjaw, where the second coupling includes a rigid link connected to thefirst jaw and the second jaw; and a knife coupled with and slidablerelative to the first jaw or the second jaw; inserting the end effectorthrough a trocar to access the anatomical structure; positioning thecartridge face on the first side of the anatomical structure;positioning the anvil face on the second side of the anatomicalstructure; operating the end effector to move the rigid link such thatthe first jaw is urged towards the second jaw to clamp the end effectoron the anatomical structure; operating the end effector to urge theplurality of staples from the cartridge to staple the anatomicalstructure; and actuating the knife to cut the anatomical structure.

Embodiments include a surgical instrument to staple and resect ananatomical structure of a patient, the surgical instrument including anend effector, the end effector including a first jaw having a first end,a second end, a longitudinal axis, and an anvil, the anvil having ananvil face positionable on the first side of the anatomical structure; asecond jaw having a first end, a second end, a longitudinal axis, and acartridge operably configured to house a plurality of staples, thecartridge having a cartridge face positionable on the second side of theanatomical structure; a first coupling that couples the first end of thefirst jaw to the first end of the second jaw; and a second coupling thatmovably couples the second end of the first jaw to the second end of thesecond jaw, where the second coupling includes a rigid link connected tothe first jaw and the second jaw; an elongate tube, the elongate tubehaving a proximal end and a distal end, where the distal end is coupledwith the end effector; a handle, the handle having a proximal end and adistal end, where the distal end of the handle is coupled with theproximal end of the elongate tube; and a drive assembly including amotor to actuate the end effector.

Embodiments include a method of stapling an anatomical structure of apatient during a minimally invasive procedure, the anatomical structurehaving a first side and a second side, the method including the steps ofproviding an end effector including an anvil having a first end, asecond end, an anvil face, a length, and a width, where the length ofthe anvil is at least ten times the width of the anvil; a cartridgehaving a first end, a second end, a cartridge face, a length, and awidth, where the length of the cartridge is at least ten times the widthof the anvil, the cartridge retaining a plurality of staples, where thefirst end of the anvil is coupled with the first end of the cartridgeand the second end of the anvil is movably coupled to the second end ofthe cartridge; and a rigid link having a distal portion and a proximalportion, where the rigid link movably couples the second end of theanvil to the second end of the cartridge; inserting the end effectorthrough a trocar to access the anatomical structure; positioning thecartridge face on the first side of the anatomical structure;positioning the anvil face on the second side of the anatomicalstructure; operating the end effector to move the rigid link such thatthe anvil is urged towards the cartridge to clamp the end effector onthe anatomical structure; operating the end effector to urge theplurality of staples from the cartridge to staple the anatomicalstructure; and actuating a knife to cut the anatomical structure.

Embodiments include a surgical instrument to staple and resect ananatomical structure of a patient, the surgical instrument including anend effector, the end effector including an anvil having a first end, asecond end, an anvil face, a length, and a width, wherein the length ofthe anvil is at least ten times the width of the anvil; a cartridgehaving a first end, a second end, a cartridge face, a length, and awidth, where the length of the cartridge is at least ten times the widthof the anvil, the cartridge being operably configured to house aplurality of staples, where the first end of the anvil is coupled withthe first end of the cartridge and the second end of the anvil ismovably coupled to the second end of the cartridge; and a rigid linkhaving a distal portion and a proximal portion, where the rigid linkmovably couples the second end of the anvil to the second end of thecartridge; an elongate tube, the elongate tube having a proximal end anda distal end, where the distal end is coupled with the end effector; ahandle, the handle having a proximal end and a distal end, where thedistal end of the handle is coupled with the proximal end of theelongate tube; and a drive assembly having a motor to actuate the endeffector.

Embodiments include a method of stapling an anatomical structure of apatient during a minimally invasive procedure, the anatomical structurehaving a first side and a second side, the method including the steps ofproviding an end effector including an anvil that includes a first end,a second end, and an anvil face; a cartridge retaining a plurality ofstaples, the cartridge having a first end, a second end, and a cartridgeface, the cartridge face including a channel extending from the firstend of the cartridge to the second end of the cartridge, where the firstend of the cartridge is pivotally coupled with the first end of theanvil; a blade, the blade having a cutting surface and at least oneelongated arm, where the at least one elongated arm is slidably engagedwith the channel; and a rigid link that movably couples the second endof the anvil to the second end of the cartridge; inserting the endeffector through a trocar to access the anatomical structure;positioning the cartridge face on the first side of the anatomicalstructure; positioning the anvil face on the second side of theanatomical structure; operating the end effector to move the rigid linksuch that the anvil is urged towards the cartridge to clamp the endeffector on the anatomical structure; operating the end effector to urgethe plurality of staples from the cartridge to staple the anatomicalstructure; and actuating the blade to cut the anatomical structure.

Embodiments include a surgical instrument to staple and resect ananatomical structure of a patient, the surgical instrument including anend effector, the end effector including an anvil that includes a firstend, a second end, and an anvil face positionable on the first side ofthe anatomical structure; a cartridge operably configured to house aplurality of staples, the cartridge comprising a first end, a secondend, and a cartridge face positionable on the second side of theanatomical structure, the cartridge face including a channel extendingfrom the first end of the cartridge to the second end of the cartridge,where the first end of the cartridge is pivotally coupled with the firstend of the anvil; a blade, the blade having a cutting surface and atleast one elongated arm, where the at least one elongated arm isslidably engaged with the channel; and a rigid link that movably couplesthe second end of the anvil to the second end of the cartridge; anelongate tube, the elongate tube having a proximal end and a distal end,where the distal end is coupled with the end effector; a handle, thehandle having a proximal end and a distal end, where the distal end ofthe handle is coupled with the proximal end of the elongate tube; and adrive assembly having a motor to actuate the end effector.

Embodiments include a method of stapling an anatomical structure of apatient during a minimally invasive procedure, the anatomical structurehaving a first side and a second side, the method including the steps ofproviding an end effector including a first jaw having a first end, asecond end, an anvil having an anvil face, and a first channel; a secondjaw having a first end, a second end, a cartridge having a cartridgeface, and a second channel; a first coupling that couples the first endof the first jaw to the first end of the second jaw; a second couplingthat movably couples the second end of the first jaw to the second endof the second jaw, where the second coupling includes a rigid link; andan I-shaped blade, the I-shaped blade including a blade portion having acutting edge, at least one upper lateral arm, where the at least oneupper lateral arm is slidably positioned in the first channel, and atleast one lower lateral arm, where the at least one lower lateral arm isslidably positioned in the second channel; inserting the end effectorthrough a trocar to access the anatomical structure; positioning thecartridge face on the first side of the anatomical structure;positioning the anvil face on the second side of the anatomicalstructure; operating the end effector to move the rigid link such thatthe anvil is urged towards the cartridge to clamp the end effector onthe anatomical structure; operating the end effector to urge theplurality of staples from the cartridge to staple the anatomicalstructure; and actuating the I-shaped blade to cut the anatomicalstructure.

Embodiments include a surgical instrument to staple and resect ananatomical structure of a patient, the surgical instrument including anend effector, the end effector including a first jaw having a first end,a second end, an anvil having an anvil face, and a first channel; asecond jaw having a first end, a second end, a cartridge having acartridge face, and a second channel; a first coupling that couples thefirst end of the first jaw to the first end of the second jaw; a secondcoupling that movably couples the second end of the first jaw to thesecond end of the second jaw, where the second coupling includes a rigidlink; and an I-shaped blade, the I-shaped blade including a bladeportion having a cutting edge, at least one upper lateral arm, where theat least one upper lateral arm is slidably positioned in the firstchannel, and at least one lower lateral arm, where the at least onelower lateral arm is slidably positioned in the second channel; and anelongate tube, the elongate tube having a proximal end and a distal end,where the distal end is coupled with the end effector; a handle, thehandle having a proximal end and a distal end, where the distal end ofthe handle is coupled with the proximal end of the elongate tube; and adrive assembly having a motor to actuate the end effector.

Embodiments include an end effector for use by a surgeon to staple ananatomical structure of a patient during a minimally invasive procedure,the end effector including an anvil having a first end, a second end,and an anvil face; a cartridge having a first end, a second end, and acartridge face, the cartridge housing a plurality of staples, where thefirst end of the anvil is coupled with the first end of the cartridgeand the second end of the anvil is coupled to the second end of thecartridge; and a buttress, the buttress including a first buttressmember, the first buttress member being coupled with the anvil face suchthat the first buttress member covers a portion of the anvil face; and asecond buttress member, the second buttress member being coupled withthe cartridge face such that the second buttress member covers a portionof the anvil face.

Embodiments include an end effector for use by a surgeon to staple ananatomical structure of a patient during a minimally invasive procedure,the end effector including an anvil that includes a first end, a secondend, and an anvil face positionable on the first side of the anatomicalstructure; a cartridge housing a plurality of staples, the cartridgehaving a first end, a second end, and a cartridge face positionable onthe second side of the anatomical structure, where the first end of thecartridge is coupled with the first end of the anvil and the second endof the cartridge is coupled with the second end of the anvil; a blade,the blade having a cutting surface, where the blade is engageable withthe anvil and the cartridge; and a buttress, the buttress being a planarsection of material coupled with the anvil face or the cartridge face.

Embodiments include an end effector including a first jaw having a firstend, a second end, an anvil having an anvil face, and a first channel; asecond jaw having a first end, a second end, a cartridge having acartridge face, and a second channel; a first coupling that couples thefirst end of the first jaw to the first end of the second jaw; a secondcoupling that couples the second end of the first jaw to the second endof the second jaw; an I-shaped blade, the I-shaped blade including ablade portion having a cutting edge; at least one upper lateral arm,where the at least one upper lateral arm is slidably positioned in thefirst channel; and at least one lower lateral arm, where the at leastone lower lateral arm is slidably positioned in the second channel; anda buttress, the buttress being a planar section of material coupled withthe anvil face or the cartridge face.

Embodiments include an end effector for use by a surgeon to staple ananatomical structure of a patient during a minimally invasive procedure,the anatomical structure having a first side and a second side, the endeffector including a first jaw having a first end, a second end, alongitudinal axis, and an anvil, the anvil having an anvil facepositionable on the first side of the anatomical structure; a second jawhaving a first end, a second end, a longitudinal axis, and a cartridgehousing a plurality of staples, the cartridge having a cartridge facepositionable on the second side of the anatomical structure; a firstcoupling that couples the first end of the first jaw to the first end ofthe second jaw; a second coupling that couples the second end of thefirst jaw to the second end of the second jaw; and a buttress, thebuttress including a first buttress member, the first buttress memberbeing positioned adjacent the anvil face such that the first buttressmember covers a portion of the anvil face; and a second buttress member,the second buttress member being positioned adjacent the cartridge facesuch that the second buttress member covers a portion of the cartridgeface.

Embodiments include a method of stapling an anatomical structure of apatient during a minimally invasive procedure, the anatomical structurehaving a first side and a second side, the method including the steps ofproviding an end effector, the end effector including a first jaw havinga first end, a second end, a longitudinal axis, and an anvil, the anvilcomprising an anvil face positionable on the first side of theanatomical structure; a second jaw having a first end, a second end, alongitudinal axis, and a cartridge housing a plurality of staples, thecartridge having a cartridge face positionable on the second side of theanatomical structure; a first coupling that couples the first end of thefirst jaw to the first end of the second jaw; and a second coupling thatcouples the second end of the first jaw to the second end of the secondjaw; providing a buttress, the buttress including a first buttressmember and a second buttress member; attaching the first buttress memberto the anvil face; attaching the second buttress member to the cartridgeface; deploying the plurality of staples to puncture the first buttressmember and the second buttress member; coupling the first buttressmember and the second buttress member to the anatomical structure withthe plurality of staples; and cutting the first buttress member and thesecond buttress member.

Embodiments include a method of stapling an anatomical structure of apatient during a minimally invasive procedure, the anatomical structurehaving a first side and a second side, the method including the steps ofproviding an end effector, the end effector including an anvil having afirst end, a second end, and an anvil face; a cartridge having a firstend, a second end, and a cartridge face, the cartridge housing aplurality of staples, where the first end of the anvil is coupled withthe first end of the cartridge and the second end of the anvil iscoupled to the second end of the cartridge; and providing a buttress,the buttress having a first buttress member and a second buttressmember; attaching the first buttress member to the anvil face; attachingthe second buttress member to the cartridge face; positioning the endeffector proximate the anatomical structure; deploying the plurality ofstaples to puncture the first buttress member and the second buttressmember; coupling the first buttress member and the second buttressmember to the anatomical structure with the plurality of staples; andcutting the first buttress member and the second buttress member.

Embodiments include an end effector for stapling an anatomicalstructure, the anatomical structure having a first side and a secondside, the end effector including an anvil, the anvil including aproximal end, a distal end, and an anvil face; an anvil blade channeldefined by the anvil face, where the anvil blade channel is positionedto bisect the anvil face into a first half and a second half; a firstpocket row including a plurality of first row staple pockets positionedon the first half of the anvil face; a second pocket row including aplurality of second row staple pockets positioned on the first half ofthe anvil face; a third pocket row including a plurality of third rowstaple pockets positioned on the first half of the anvil face; a fourthpocket row including a plurality of fourth row staple pockets positionedon the second half of the anvil face; a fifth pocket row including aplurality of fifth row staple pockets positioned on the second half ofthe anvil face; and a sixth pocket row including a plurality of sixthrow staple pockets positioned on the second half of the anvil face; acartridge having a proximal end, a distal end, and a cartridge facedefining a cartridge blade channel, the cartridge being configured toretain a plurality of staples; and a blade, the blade having a cuttingedge, wherein the blade is movable from a first position at the distalend of the cartridge to a second position at the proximal end of thecartridge.

Embodiments of the end effector can include a staple driver rampoperably configured to urge the plurality of staples from the cartridgetowards the anvil face, where the staple driver ramp is movable from thedistal end of the end effector to the proximal end of the end effectorsuch that the end effector is operably configured to deploy theplurality of staples from the cartridge as the blade is moved from thedistal end to the proximal end. In certain embodiments, the proximal endof the anvil is coupled with the proximal end of the cartridge and thedistal end of the anvil is coupled with the distal end of the cartridge.In certain embodiments, the plurality of first row staple pockets has auniform first depth, the plurality of second row staple pockets has auniform second depth, and the uniform first depth is different from theuniform second depth. In certain embodiments, the uniform first depth isshallower than the uniform second depth. In certain embodiments, thefirst pocket row is spaced apart a first distance from the second pocketrow, the second pocket row is spaced apart a second distance from thethird pocket row, and the second distance is greater than the firstdistance. In certain embodiments, the first pocket row is offset fromthe second pocket row. In certain embodiments, the plurality of firstrow staple pockets includes a first portion having a first pocket depthand a second portion having a second pocket depth. In certainembodiments, the first portion is a proximal portion, the second portionis a distal portion, and the first pocket depth is deeper than thesecond pocket depth. In certain embodiments, each of the plurality offirst row staple pockets has a different pocket depth. In certainembodiments, the plurality of first row staple pockets have a firstdepth corresponding with the plurality of fourth row staple pockets, theplurality of second row staple pockets have a second depth correspondingwith the plurality of fifth row staple pockets, and the plurality ofthird row staple pockets have a third depth corresponding with theplurality of sixth row staple pockets. In certain embodiments, the firstdepth is shallower than the second depth and the second depth isshallower than the third depth. In certain embodiments, each of theplurality of first row staple pockets is sized to form a B-shapedstaple, having a symmetrical configuration, in cooperation with thecartridge face. In certain embodiments, at least a portion of theplurality of first row staple pockets are sized to form a staple havingan asymmetrical configuration. In certain embodiments, each of theplurality of first row staple pockets is sized to form a staple having athree-dimensional geometry. In certain embodiments, each of theplurality of first row staple pockets includes a first cavity having afirst depth and a second cavity having a second depth, where the firstdepth is greater than the second depth.

Certain embodiments include an end effector for stapling an anatomicalstructure, the anatomical structure having a first side and a secondside, the end effector including an anvil, the anvil including aproximal end, a distal end, and an anvil face; an anvil blade channeldefined by the anvil face, where the anvil blade channel is positionedto bisect the anvil face into a first half and a second half; a firstpocket row including a plurality of first row staple pockets positionedon the first half of the anvil face, where a first portion of theplurality of first row staple pockets has a first pocket depth and asecond portion of the plurality of first row staple pockets has a secondpocket depth different from the first pocket depth; a second pocket rowincluding a plurality of second row staple pockets positioned on thefirst half of the anvil face, where a first portion of the plurality ofsecond row staple pockets has the first pocket depth and a secondportion of the plurality of second row staple pockets has the secondpocket depth; a third pocket row including a plurality of third rowstaple pockets positioned on the second half of the anvil face, where afirst portion of the plurality of third row staple pockets has the firstpocket depth and a second portion of the plurality of third row staplepockets has the second pocket depth; and a fourth pocket row including aplurality of fourth row staple pockets positioned on the second half ofthe anvil face, where a first portion of the plurality of fourth rowstaple pockets has the first pocket depth and a second portion of theplurality of fourth row staple pockets has the second pocket depth; acartridge having a proximal end, a distal end, and a cartridge facedefining a cartridge blade channel, the cartridge being configured toretain a plurality of staples; and a blade, the blade having a cuttingedge, where the blade is movable from a first position at the distal endof the cartridge to a second position at a proximal end of thecartridge.

Embodiments include an end effector for stapling an anatomicalstructure, the anatomical structure having a first side and a secondside, the end effector including an anvil, the anvil having a proximalend, a distal end, and an anvil face; an anvil blade channel defined bythe anvil face, where the knife channel bisects the anvil face into afirst half and a second half; a first inner pocket row including aplurality of first row staple pockets positioned on the first half ofthe anvil face, where each of the plurality of first row staple pocketshas a depth of from 0.010 inches to 0.015 inches; a second middle pocketrow including a plurality of second row staple pockets positioned on thefirst half of the anvil face, where each of the plurality of second rowstaple pockets has a depth of from 0.020 inches to 0.025 inches; a thirdouter pocket row including a plurality of third row staple pocketspositioned on the first half of the anvil face, where each of theplurality of third row staple pockets has a depth from 0.030 inches to0.035 inches; a fourth inner pocket row including a plurality of fourthrow staple pockets positioned on the second half of the anvil face,where each of the plurality of fourth row staple pockets has a depth offrom 0.010 inches to 0.050 inches; a fifth middle pocket row including aplurality of fifth row staple pockets positioned on the second half ofthe anvil face, where each of the plurality of fifth row staple pocketshas a depth of from 0.010 inches to 0.050 inches; and a sixth outerpocket row including a plurality of sixth row staple pockets positionedon the second half of the anvil face, where each of the plurality ofsixth row staple pockets has a depth from 0.010 inches to 0.050 inches;a cartridge having a proximal end, a distal end, and a cartridge facedefining a cartridge blade channel, the cartridge being configured toretain a plurality of staples; and a blade, the blade having a cuttingedge, wherein the blade is movable from a first position at the distalend of the cartridge to a proximal end of the cartridge.

Embodiments include an end effector for use by a surgeon to staple ananatomical structure of a patient during a minimally invasive procedure,the anatomical structure having a first side and a second side, the endeffector including an anvil comprising a first end, a second end, ananvil face, a length, and a width, where the length of the anvil is atleast ten times the width of the anvil; a cartridge having a first end,a second end, a cartridge face, a length, and a width, where the lengthof the cartridge is at least ten times the width of the anvil, thecartridge being operably configured to house a plurality of staples,where the first end of the anvil is coupled with the first end of thecartridge and the second end of the anvil is movably coupled to thesecond end of the cartridge; and a rigid link having a distal portionand a proximal portion, where the rigid link movably couples the secondend of the anvil to the second end of the cartridge.

Embodiments include an end effector for use by a surgeon to staple ananatomical structure of a patient during a minimally invasive procedure,the anatomical structure having a first side and a second side, the endeffector including an anvil that includes a first end, a second end, andan anvil face positionable on the first side of the anatomicalstructure, a cartridge operably configured to house a plurality ofstaples, the cartridge including a first end, a second end, and acartridge face positionable on the second side of the anatomicalstructure, the cartridge face including a channel extending from thefirst end of the cartridge to the second end of the cartridge, where thefirst end of the cartridge is pivotally coupled with the first end ofthe anvil; a blade, the blade including a cutting surface and at leastone elongated arm, where the at least one elongated arm is slidablyengaged with the channel; and a rigid link that movably couples thesecond end of the anvil to the second end of the cartridge.

Embodiments include an end effector including a first jaw having a firstend, a second end, an anvil having an anvil face, and a first channel; asecond jaw having a first end, a second end, a cartridge having acartridge face, and a second channel; a first coupling that couples thefirst end of the first jaw to the first end of the second jaw; a secondcoupling that movably couples the second end of the first jaw to thesecond end of the second jaw, where the second coupling includes a rigidlink; and an I-shaped blade, the I-shaped blade including a bladeportion having a cutting edge, at least one upper lateral arm, where theat least one upper lateral arm is slidably positioned in the firstchannel, and at least one lower lateral arm, where the at least onelower lateral arm is slidably positioned in the second channel.

Embodiments are directed to an end effector for use by a surgeon tostaple an anatomical structure of a patient during a minimally invasiveprocedure, the anatomical structure having a first side and a secondside. The end effector includes a first jaw having a first end, a secondend, a longitudinal axis, and an anvil, the anvil having an anvil facepositionable on the first side of the anatomical structure. A second jawhas a first end, a second end, a longitudinal axis, and a cartridgeoperably configured to house a plurality of staples, the cartridgehaving a cartridge face positionable on the second side of theanatomical structure. A first coupling couples the first end of thefirst jaw to the first end of the second jaw, and a second couplingmovably couples the second end of the first jaw to the second end of thesecond jaw, wherein the second coupling includes a rigid link.

The first end of the first jaw may be a distal end of the first jaw andthe second end of the first jaw may be a proximal end of the first jaw.The first coupling may include a pin having a pin axis, the pin axisbeing transverse to the longitudinal axis of the first jaw and thelongitudinal axis of the second jaw, wherein the pin pivotally couplesthe first end of the first jaw to the first end of the second jaw.

The second coupling may include a slot within the first jaw or thesecond jaw that retains the rigid link such that the rigid link may beslidable within the slot. The slot may have a length of from 3millimeters to 8 millimeters. A plurality of staples may be at leastpartially retained by the cartridge of the second jaw. The plurality ofstaples retained at least partially by the cartridge may be positionedbetween the first coupling and the second coupling. The end effector mayfurther have a blade with a cutting surface and at least one lateralarm. There may also be a channel defined by the first jaw or the secondjaw to retain the lateral arm of the blade. The blade may be transitionfrom a first position at a distal end of the end effector to a secondposition at a proximal end of the end effector such that the anatomicalstructure may be resected.

In another embodiment an end effector for use by a surgeon to staple ananatomical structure of a patient having a first side and a second sideduring a minimally invasive procedure is disclosed. The end effectorincludes an anvil having a first end, a second end, an anvil face, alength, and a width, wherein the length of the anvil may be at least tentimes the width of the anvil. The end effector also includes a cartridgehaving a first end, a second end, a cartridge face, a length, and awidth, wherein the length of the cartridge may be at least ten times thewidth of the anvil. The cartridge may be operably configured to house aplurality of staples, wherein the first end of the anvil may be coupledwith the first end of the cartridge and the second end of the anvil maybe movably coupled to the second end of the cartridge.

A rigid link having a distal portion and a proximal portion may movablycouple the second end of the anvil to the second end of the cartridge.The end effector may further have a control unit that is operable tomove the rigid link in a first direction such that the anvil and thecartridge are spaced apart a first distance in a first position. Thecontrol unit may also be operable to move the rigid link a seconddirection such that the anvil and the cartridge are spaced apart asecond distance in a second position, wherein the first distance may begreater than the second distance. For example, the first direction maybe a distal direction and the second direction may be a proximaldirection. The distal portion of the rigid link may be connected to theend effector, and the proximal portion of the rigid link may beconnected to a control unit.

In another embodiment, the end effector may further have a ramp, whereinthe rigid link may include a ramp surface operably configured such thatwhen the ramp surface of the rigid link engages the ramp, the endeffector transitions from a closed position to an open position. Therigid link may include an angled surface operably configured such thatwhen the angled surface of the rigid link engages an elongate tubecoupled with the end effector, the end effector transitions from an openposition to a closed position. The end effector may further have anelongated slot defined by the anvil or cartridge that slidably retainsthe rigid link. The end effector may further have a blade with a cuttingsurface and at least one lateral arm, wherein the lateral arm may beslidably engaged with a channel defined by the anvil or cartridge. Theblade may be transitioned from a first position at a distal end of theend effector to a second position at a proximal end of the end effectorsuch that the anatomical structure may be resected.

In another embodiment an end effector for use by a surgeon to staple ananatomical structure of a patient has an anvil that includes a firstend, a second end, and an anvil face positionable on the first side ofthe anatomical structure. A cartridge may be provided on theend-effector that is operably configured to house a plurality ofstaples, where the cartridge has a first end, a second end, and acartridge face positionable on the second side of the anatomicalstructure. The cartridge face may include a channel extending from thefirst end of the cartridge to the second end of the cartridge, whereinthe first end of the cartridge may be pivotally coupled with the firstend of the anvil. A blade may have a cutting surface and at least oneelongated arm, wherein the elongated arm may be slidably engaged withthe channel. A rigid link may movably couple the second end of the anvilto the second end of the cartridge.

In one embodiment, at least one elongated arm of the blade urges each ofa plurality of staples from the cartridge as the blade is advanced froma first position at a distal end of the cartridge to a second positionat a proximal end of the cartridge. The blade may be I-shaped such thatthe blade compresses the anvil and the cartridge together during use.The first end of the cartridge may be a distal end and the second end ofthe cartridge may be a proximal end. The rigid link may be amonolithically formed unitary structure. The first end of the cartridgemay be pivotally coupled with the first end of the anvil.

In another embodiment, an end effector is disclosed as having a firstjaw having a first end, a second end, an anvil having an anvil face, anda first channel; a second jaw having a first end, a second end, acartridge having a cartridge face, and a second channel; a firstcoupling that couples the first end of the first jaw to the first end ofthe second jaw; a second coupling that movably couples the second end ofthe first jaw to the second end of the second jaw, wherein the secondcoupling includes a rigid link; and an I-shaped blade. The I-shapedblade has a blade portion having a cutting edge; at least one upperlateral arm, wherein the at least one upper lateral arm may be slidablypositioned in the first channel; and at least one lower lateral arm,wherein the at least one lower lateral arm may be slidably positioned inthe second channel. The cartridge may include a plurality of staples.

In a further embodiment, a surgical instrument to staple and resect ananatomical structure of a patient is disclosed, the surgical instrumenthaving: an end effector having; a first jaw having a first end, a secondend, a longitudinal axis, and an anvil, the anvil having an anvil facepositionable on the first side of the anatomical structure; a second jawhaving a first end, a second end, a longitudinal axis, and a cartridgeoperably configured to house a plurality of staples, the cartridgehaving a cartridge face positionable on the second side of theanatomical structure; a first coupling that couples the first end of thefirst jaw to the first end of the second jaw; and a second coupling thatmovably couples the second end of the first jaw to the second end of thesecond jaw, wherein the second coupling includes a rigid link connectedto the first jaw and the second jaw. The device may include a driveassembly having a motor that actuates the end effector.

The device may further include an elongate tube, the elongate tubehaving a proximal end and a distal end, wherein the distal end may becoupled with the end effector; and a handle, the handle having aproximal end and a distal end, wherein the distal end of the handle maybe coupled with the proximal end of the elongate tube. For example, thefirst end of the first jaw may be a distal end of the first jaw and thesecond end of the first jaw may be a proximal end of the first jaw. Thefirst coupling may include a pin having a pin axis, the pin axis beingtransverse to the longitudinal axis of the first jaw and thelongitudinal axis of the second jaw, wherein the pin pivotally couplesthe first end of the first jaw to the first end of the second jaw. Thesecond coupling may include a slot defined by the first jaw or thesecond jaw that retains the rigid link such that the rigid link may beslidable within the slot. The slot may have a length of from 3millimeters to 8 millimeters. A plurality of staples may be at leastpartially retained by the cartridge of the second jaw, and may bepositioned between the first coupling and the second coupling. The blademay have a cutting surface and at least one lateral arm, and a channelmay be defined by the first jaw or the second jaw to retain the lateralarm of the blade. The blade may be transitioned from a first position ata distal end of the end effector to a second position at a proximal endof the end effector such that the anatomical structure may be resected.

In another embodiment, a surgical instrument to staple and resect ananatomical structure of a patient is described as having an end effectorwith an anvil having a first end, a second end, an anvil face, a length,and a width, wherein the length of the anvil may be at least ten timesthe width of the anvil; a cartridge having a first end, a second end, acartridge face, a length, and a width, wherein the length of thecartridge may be at least ten times the width of the anvil, thecartridge being operably configured to house a plurality of staples,wherein the first end of the anvil may be coupled with the first end ofthe cartridge and the second end of the anvil may be movably coupled tothe second end of the cartridge; and a rigid link having a distalportion and a proximal portion, wherein the rigid link movably couplesthe second end of the anvil to the second end of the cartridge. Theinstrument may include an elongate tube, the elongate tube having aproximal end and a distal end, wherein the distal end may be coupledwith the end effector; and a handle, the handle having a proximal endand a distal end, wherein the distal end of the handle may be coupledwith the proximal end of the elongate tube. The instrument may include adrive assembly having a motor that actuates the end effector.

The instrument may further have a control unit connected to the endeffector, wherein the control unit may be operable to move the rigidlink a first direction such that the anvil and the cartridge are spacedapart a first distance in a first position, and the control unit may beoperable to move the rigid link a second direction such that the anviland the cartridge are spaced apart a second distance in a secondposition, wherein the first distance may be greater than the seconddistance. The control unit may include a drive assembly having a motorthat actuates the end effector.

For example, the first direction may be a distal direction and thesecond direction may be a proximal direction. A distal portion of therigid link may be connected to the end effector and the proximal portionof the rigid link may be connected to the control unit. The surgicalinstrument may further have a ramp, wherein the rigid link may include aramp surface operably configured such that when the ramp surface of therigid link engages the ramp the end effector transitions from a closedposition to an open position. The rigid link may also include an angledsurface operably configured such that when the angled surface of therigid link engages the elongate tube coupled with the end effector, theend effector transitions from an open position to a closed position.

The surgical instrument may further have an elongated slot defined bythe anvil or cartridge that slidably retains the rigid link, and a bladehaving a cutting surface and at least one lateral arm, wherein the atleast one lateral arm may be slidably engaged with a channel defined bythe anvil or cartridge. The blade may be transitioned from a firstposition at a distal end of the end effector to a second position at aproximal end of the end effector such that the anatomical structure maybe resected.

In yet another embodiment, a surgical instrument to staple and resect ananatomical structure of a patient is disclosed as having an end effectorwith: an anvil that includes a first end, a second end, and an anvilface positionable on the first side of the anatomical structure; acartridge operably configured to house a plurality of staples, thecartridge having a first end, a second end, and a cartridge facepositionable on the second side of the anatomical structure, thecartridge face including a channel extending from the first end of thecartridge to the second end of the cartridge, wherein the first end ofthe cartridge may be pivotally coupled with the first end of the anvil;a blade, the blade having a cutting surface and at least one elongatedarm, wherein the at least one elongated arm may be slidably engaged withthe channel; and a rigid link that movably couples the second end of theanvil to the second end of the cartridge. The instrument may furtherinclude an elongate tube, the elongate tube having a proximal end and adistal end, wherein the distal end may be coupled with the end effector;and a handle, the handle having a proximal end and a distal end, whereinthe distal end of the handle may be coupled with the proximal end of theelongate tube. A plurality of staples may be housed at least partiallyby the cartridge. At least one elongated arm of the blade may be used tourge each of the plurality of staples from the cartridge as the bladeadvances from a first position at a distal end of the cartridge to asecond position at a proximal end of the cartridge. The blade may beI-shaped such that the blade compresses the anvil and the cartridgeduring use.

In another embodiment, a surgical instrument useful to staple and resectan anatomical structure of a patient is disclosed as having an endeffector with: a first jaw having a first end, a second end, an anvilhaving an anvil face, and a first channel; a second jaw having a firstend, a second end, a cartridge having a cartridge face, and a secondchannel; a first coupling that couples the first end of the first jaw tothe first end of the second jaw; a second coupling that movably couplesthe second end of the first jaw to the second end of the second jaw,wherein the second coupling includes a rigid link; and an I-shapedblade, the I-shaped blade having a blade portion with a cutting edge, atleast one upper lateral arm, wherein the at least one upper lateral armmay be slidably positioned in the first channel, and at least one lowerlateral arm, wherein the at least one lower lateral arm may be slidablypositioned in the second channel.

The surgical instrument may further have an elongate tube with aproximal end and a distal end, wherein the distal end may be coupledwith the end effector; and a handle, the handle having a proximal endand a distal end, wherein the distal end of the handle may be coupledwith the proximal end of the elongate tube. At least one lower lateralarm may be operably configured to urge each of a plurality of staplesfrom the cartridge when the I-shaped blade is actuated from a firstposition at a distal end of the end effector to a second position at aproximal end of the end effector.

In still a further embodiment, a method of stapling an anatomicalstructure of a patient during a minimally invasive procedure isdisclosed, having the steps of: providing an end effector having; afirst jaw having a first end, a second end, a longitudinal axis, and ananvil, the anvil having an anvil face; a second jaw having a first end,a second end, a longitudinal axis, and a cartridge retaining a pluralityof staples, the cartridge having a cartridge face; a first coupling thatcouples the first end of the first jaw to the first end of the secondjaw; a second coupling that movably couples the second end of the firstjaw to the second end of the second jaw, wherein the second couplingincludes a rigid link connected to the first jaw and the second jaw; anda knife coupled with and slidable relative to the first jaw or thesecond jaw. The method further includes the steps of: inserting the endeffector through a trocar to access the anatomical structure;positioning the cartridge face on the first side of the anatomicalstructure; positioning the anvil face on the second side of theanatomical structure; operating the end effector to move the rigid linksuch that the first jaw may be urged towards the second jaw to clamp theend effector on the anatomical structure; operating the end effector tourge the plurality of staples from the cartridge to staple theanatomical structure; and actuating the knife to cut the anatomicalstructure.

The first end of the first jaw may be a distal end of the first jaw andthe second end of the first jaw may be a proximal end of the first jaw.The first coupling may include a pin having a pin axis, the pin axisbeing transverse to the longitudinal axis of the first jaw and thelongitudinal axis of the second jaw, wherein the pin pivotally couplesthe first end of the first jaw to the first end of the second jaw. Thesecond coupling may include a slot defined by the first jaw or thesecond jaw that retains the rigid link such that the rigid link may beslidable within the slot.

Operating the end effector to urge the plurality of staples from thecartridge and actuating the knife to cut the anatomical structure mayoccur simultaneously. Actuating the knife to cut the anatomicalstructure may include advancing the knife from a first distal positionto a second proximal position. Operating the end effector to urge theplurality of staples from the cartridge to staple the anatomicalstructure may include urging the plurality of staples from the cartridgebetween the first coupling and the second coupling. Actuating the knifeto cut the anatomical structure may include advancing at least a portionof the knife through a channel defined by the first jaw or the secondjaw. The knife may be transitioned from a first position at a distal endof the end effector to a second position at a proximal end of the endeffector such that the anatomical structure may be resected.

In another embodiment, a method of stapling an anatomical structure of apatient during a minimally invasive procedure is described as having thesteps of: providing an end effector having; an anvil having a first end,a second end, an anvil face, a length, and a width, wherein the lengthof the anvil may be at least ten times the width of the anvil; acartridge having a first end, a second end, a cartridge face, a length,and a width, wherein the length of the cartridge may be at least tentimes the width of the anvil, the cartridge retaining a plurality ofstaples, wherein the first end of the anvil may be coupled with thefirst end of the cartridge and the second end of the anvil may bemovably coupled to the second end of the cartridge; and a rigid linkhaving a distal portion and a proximal portion, wherein the rigid linkmovably couples the second end of the anvil to the second end of thecartridge; inserting the end effector through a trocar to access theanatomical structure; positioning the cartridge face on the first sideof the anatomical structure; positioning the anvil face on the secondside of the anatomical structure; operating the end effector to move therigid link such that the anvil may be urged towards the cartridge toclamp the end effector on the anatomical structure; operating the endeffector to urge the plurality of staples from the cartridge to staplethe anatomical structure; and actuating a knife to cut the anatomicalstructure.

The method may further utilize a control unit connected to the endeffector, wherein the control unit may be operable to move the rigidlink a first direction such that the anvil and the cartridge are spacedapart a first distance in a first position. The control unit may beoperable to move the rigid link a second direction such that the anviland the cartridge are spaced apart a second distance in a secondposition, wherein the first distance may be greater than the seconddistance. For example, the first direction may be a distal direction andthe second direction may be a proximal direction. The distal portion ofthe rigid link may be connected to the end effector and the proximalportion of the rigid link may be connected to a control unit. Operatingthe end effector to urge the plurality of staples from the cartridge andactuating the knife to cut the anatomical structure may occursimultaneously. Actuating the knife to cut the anatomical structure mayinclude forming a sleeve in accordance with a sleeve gastrectomyprocedure.

In yet another embodiment, a method of stapling an anatomical structureof a patient during a minimally invasive procedure is described, theanatomical structure having a first side and a second side, the methodhaving the steps of: providing an end effector having; an anvil thatincludes a first end, a second end, and an anvil face; a cartridgeretaining a plurality of staples, the cartridge having a first end, asecond end, and a cartridge face, the cartridge face including a channelextending from the first end of the cartridge to the second end of thecartridge, wherein the first end of the cartridge may be pivotallycoupled with the first end of the anvil; a blade, the blade having acutting surface and at least one elongated arm, wherein the at least oneelongated arm may be slidably engaged with the channel; and a rigid linkthat movably couples the second end of the anvil to the second end ofthe cartridge. The method further includes the steps of: inserting theend effector through a trocar to access the anatomical structure;positioning the cartridge face on the first side of the anatomicalstructure; positioning the anvil face on the second side of theanatomical structure; operating the end effector to move the rigid linksuch that the anvil may be urged towards the cartridge to clamp the endeffector on the anatomical structure; operating the end effector to urgethe plurality of staples from the cartridge to staple the anatomicalstructure; and actuating the blade to cut the anatomical structure.

In still a further embodiment of a method of stapling an anatomicalstructure of a patient during a minimally invasive procedure, the methodinvolves the steps of: providing an end effector having; a first jawhaving a first end, a second end, an anvil having an anvil face, and afirst channel; a second jaw having a first end, a second end, acartridge having a cartridge face, and a second channel; a firstcoupling that couples the first end of the first jaw to the first end ofthe second jaw; a second coupling that movably couples the second end ofthe first jaw to the second end of the second jaw, wherein the secondcoupling includes a rigid link; and an I-shaped blade, the I-shapedblade having; a blade portion having a cutting edge; at least one upperlateral arm, wherein the at least one upper lateral arm may be slidablypositioned in the first channel; and at least one lower lateral arm,wherein the at least one lower lateral arm may be slidably positioned inthe second channel. The method further involves the steps of: insertingthe end effector through a trocar to access the anatomical structure;positioning the cartridge face on the first side of the anatomicalstructure; positioning the anvil face on the second side of theanatomical structure; operating the end effector to move the rigid linksuch that the anvil may be urged towards the cartridge to clamp the endeffector on the anatomical structure; operating the end effector to urgethe plurality of staples from the cartridge to staple the anatomicalstructure; and actuating the I-shaped blade to cut the anatomicalstructure. The anatomical structure may be a stomach and actuating theI-shaped blade to cut the anatomical structure may include forming asleeve in accordance with a sleeve gastrectomy procedure.

At least one lower lateral arm may be operably configured to urge eachof the plurality of staples from the cartridge when the I-shaped bladeis actuated from a first position at a distal end of the end effector toa second position at a proximal end of the end effector. At least onelower lateral arm may be operably configured to urge each of theplurality of staples from the cartridge when the I-shaped blade isactuated from a first position at a distal end of the end effector to asecond position at a proximal end of the end effector.

In one embodiment, an end effector is disclosed for use by a surgeon tostaple an anatomical structure of a patient during a minimally invasiveprocedure. The anatomical structure has a first side and a second side.The end effector includes a first jaw having a first end, a second endand an anvil having an anvil face that may be positionable on the firstside of the anatomical structure. A second jaw having a first end, asecond end and a cartridge housing a plurality of staples is alsoincluded, the cartridge having a cartridge face that may be positionableon the second side of the anatomical structure.

A first coupling couples the first end of the first jaw to the first endof the second jaw, and a second coupling is included that movablycouples the second end of the first jaw to the second end of the secondjaw, wherein the second coupling includes a rigid link that is movablycoupled to the first and second jaws. The end effector may have alongitudinal axis, wherein the first coupling includes a pin thatrotatably couples the first jaw to the second jaw, wherein the rotationabout the pin is transverse to the longitudinal axis. The pin thatrotatably couples the first jaw to the second jaw may be slidablyreceived within a slot in at least one of the first jaw or the secondjaw.

At least one of the first jaw or the second jaw may slidably receive therigid link within a slot as the first jaw is moved toward the secondjaw. The rigid link may be coupled to the first jaw using a slot thatallows motion of the rigid link in a first direction but limits motionof the rigid link in a direction perpendicular to the first direction.In one embodiment, the rigid link pushes the anvil open in theperpendicular direction. The slot may have a length of about 3 to about8 millimeters, and preferably has a length of about 6 to about 7millimeters. The plurality of staples may be positioned between thefirst coupling and the second coupling. The end effector may include ablade having a cutting surface and an elongated arm, the elongated armextending at least from the blade positionable near the second end ofthe cartridge to the first end of the cartridge, where the arm slidablyengages a cartridge channel.

In one particular embodiment, a surgical instrument is used to staple ananatomical structure of a patient, the anatomical structure having afirst side and a second side. The surgical instrument may include anelongated end effector having a length and a width, wherein the lengthis at least ten times the width, the length defining a longitudinalaxis, the longitudinal axis defining an axial direction perpendicular tothe longitudinal axis. An anvil of the instrument may include a firstend, a second end, and an anvil face. The instrument may also have acartridge housing a plurality of staples that includes a first end, asecond end, and a cartridge face, wherein the second end of the anvilmay be movably coupled to the second end of the cartridge, wherein atleast one of the anvil and the cartridge may include an elongated slothaving its direction of elongation along the longitudinal axis. A rigidlink may movably couple the first end of the anvil to the first end ofthe cartridge, wherein the rigid link may be retained within theelongated slot such that the rigid link is slidable along the elongatedslot but limited in motion of the rigid link within the elongated slotin the axial direction. The surgical instrument may further include acontrol unit connected to the end effector by a tube along thelongitudinal direction, wherein the control unit is operable to move therigid link and separate the anvil and cartridge apart in the axialdirection.

The elongated slot may allow longitudinal movement of the rigid linkrelative to the tube. The handle may operate to push the rigid link outof the tube and pull the rigid link into the tube. The rigid link mayinclude a distal portion connected to the end effector and a proximalportion connected to the handle, wherein the end effector includes aramp adjacent to the distal portion of the rigid link, the ramp beingpositioned to urge the rigid link in the axial direction as the rigidlink moves distally.

The rigid link may include a ramp surface that slides along the ramp asthe rigid link moves distally. The rigid link may include a distalportion connected to the end effector and a proximal portion connectedto the handle, wherein the rigid link includes an angled surface betweenthe distal portion and the proximal portion that engages the tube as therigid link is pulled proximally by the handle, the tube engagementmoving the anvil face and the cartridge face relative to one another.

The elongated slot may be offset from the longitudinal axis. Further,the elongated slot may have an elongation axis that intersects thelongitudinal axis. The end effector may include a blade having a cuttingsurface and an elongated arm, the elongated arm extending at least fromthe blade positionable near the second end of the cartridge to the firstend of the cartridge, where the arm slidably engages with a cartridgechannel.

In another embodiment, an end effector for use by a surgeon to staple ananatomical structure of a patient during a minimally invasive procedureincludes an anvil that includes a first end, a second end, and an anvilface that may be positionable on the first side of the anatomicalstructure. The end effector further includes a cartridge housing aplurality of staples that include a first end, a second end, and acartridge face that may be positionable on the second side of theanatomical structure. The cartridge face may include a channel extendingfrom the second end to the first end, where a blade having a cuttingsurface and an elongated arm extending at least from the bladepositionable near the second end of the cartridge to the first end ofthe cartridge engages with the cartridge channel. A rigid link maymovably couple the first end of the anvil to the first end of thecartridge, wherein the second end of the anvil may be movably coupled tothe second end of the cartridge. Each of the anvil and the cartridge maybe insertable through a trocar and the end effector may be remotelyoperable from outside the patient with at least a portion of one of theanvil and the cartridge being movable toward the other to clamp the endeffector to the anatomical structure.

The elongated arm of the blade may fill the cartridge channel proximallyfrom the blade as the blade is moved from the second end to the firstend, thereby forming staples in the anatomical structure as the bladecuts the anatomical structure. The blade may include an I-shaped portionhaving a top portion and a bottom portion connected by a middle bladeportion, where the middle blade portion has a sharp cutting edge. Theanvil includes a first opening near its first end and a second openingnear its second end, each of the first opening and second openingoperable to removably receive the top portion of the I-shaped portionwhen the anvil is approached to or departed from the cartridge. Theelongated arm of the blade may fill the cartridge channel proximallyfrom the blade as the blade is moved from the second end to the firstend thereby forming staples in the anatomical structure as the bladecuts the anatomical structure.

The surgical instrument may further include a control unit connected tothe end effector by a tube along the longitudinal direction, wherein thecontrol unit is operable to move the rigid link and separate the anviland cartridge apart in the axial direction. The rigid link may include adistal portion connected to the end effector and a proximal portionconnected to the handle, wherein the end effector may include a rampadjacent to the distal portion of the rigid link, the ramp positioned tourge the link in the axial direction as the link moves distally. Therigid link may include a ramp surface that slides along the ramp as therigid link moves distally.

In a further embodiment, a stapler includes a first jaw having a firstend, a second end and an anvil having an anvil face, a second jaw havinga first end, a second end and a cartridge housing a plurality ofstaples, the cartridge having a cartridge face and a cartridge channelalong the length of the cartridge. There is a first coupling thatcouples the first jaw to the second jaw and a second coupling thatmovably couples the second end of the first jaw to the second end of thesecond jaw, wherein the second coupling includes a rigid link that ismovably coupled to the first and second jaws. A blade may be includedthat has an I-shaped portion having a top portion and a bottom portionconnected by a middle blade portion, the middle blade portion having asharp cutting edge, wherein the anvil has a first opening near its firstend and a second opening near its second end, each of the first openingand second opening operable to removably receive the top portion of theI-shaped portion when the anvil is approached to or departed from thecartridge.

The stapler may include a rigid link that is retained within anelongated slot such that the rigid link is slidable along the elongatedslot in a first direction but limited in motion of the rigid link withinthe elongated slot in a second direction. The elongated slot may beoffset from a longitudinal axis of the stapler.

In still a further embodiment, a method of stapling an anatomicalstructure of a patient during a minimally invasive procedure isdisclosed, where the anatomical structure has a first side and a secondside. The method may include the steps of: providing a stapler with anend effector having a first jaw having a first end, a second end and ananvil having an anvil face; a second jaw having a first end, a secondend and a cartridge housing a plurality of staples, the cartridge havinga cartridge face; a first coupling that couples the first jaw to thesecond jaw; and a second coupling that movably couples the second end ofthe first jaw to the second end of the second jaw, wherein the secondcoupling includes a link that is movably coupled to the first and secondjaws; inserting the end effector through a trocar to access theanatomical structure; positioning the cartridge face on the first sideof the anatomical structure; positioning the anvil face on the secondside of the anatomical structure; remotely operating the stapler fromoutside the patient to move the link such that at least a portion of oneof the anvil or the cartridge is moved toward the other to clamp the endeffector on the anatomical structure; and firing the stapler tosimultaneously staple and cut the anatomical structure.

The end effector may have a longitudinal axis, wherein the firstcoupling includes a pin that rotatably couples the first jaw to thesecond jaw, wherein the rotation about the pin is transverse to thelongitudinal axis. The method may further include the step of slidablyreceiving the link within a slot in at least one of the anvil or thecartridge when the end effector is clamped onto the anatomicalstructure, wherein the link is rigid. The rigid link may be coupled tothe anvil using the slot such that the slot allows motion of the rigidlink within the slot in a first direction but limits motion of the rigidlink within the slot in a direction substantially perpendicular to thefirst direction. The rigid link may be coupled to the cartridge usingthe slot such that the slot allows motion of the rigid link in a firstdirection within the slot but the slot limits motion of the rigid linkwithin the slot in a direction substantially perpendicular to the firstdirection.

The rigid link may be movable within the slot in the first directionover a length of about 3 to about 8 millimeters, and preferably therigid link may be movable within the slot in the first direction througha length of about 7 millimeters. In one embodiment, the first couplingis distal to the second coupling and the method further includes thestep of compressing the anatomical structure between the first couplingand the second coupling.

In a further embodiment, a method of using a surgical instrument tostaple an anatomical structure of a patient is disclosed, where theanatomical structure has a first side and a second side, and the methodincludes the steps of: providing an elongated end effector having alength and a width, wherein the length is at least ten times the width,the length defining a longitudinal direction, the longitudinal directiondefining an axial direction substantially perpendicular to thelongitudinal direction; providing an anvil on the end effector thatincludes a first end, a second end, and an anvil face; providing acartridge on the end effector that houses a plurality of staples andthat includes a first end, a second end, and a cartridge face, whereinthe second end of the anvil is movably coupled to the second end of thecartridge, wherein at least one of the anvil and the cartridge includesan elongated slot having its direction of elongation substantially alongthe longitudinal direction; actuating a rigid link that movably couplesthe first end of the anvil to the first end of the cartridge; andretaining the rigid link within the elongated slot as the surgicalinstrument is actuated such that the rigid link slides within theelongated slot along the longitudinal direction but is substantiallylimited in motion of the rigid link within the elongated slot in theaxial direction.

The method may further include using a handle connected to the endeffector by a tube along the longitudinal direction, wherein the methodfurther includes the step of operating the handle to move the rigid linkand separate the anvil and cartridge apart in the axial direction. Thehandle may operate to push the rigid link out of the tube and pull therigid link into the tube. The rigid link may include a distal portionconnected to the end effector and a proximal portion connected to thehandle, wherein the end effector includes a ramp adjacent to the distalportion of the rigid link, wherein the method further includes the stepof pushing the rigid link onto the ramp urging the rigid link in theaxial direction as the rigid link is pushed. The rigid link may includea ramp surface, wherein the method further may include the step ofsliding the ramp surface along the ramp as the rigid link moves. Therigid link may alternately include a distal portion connected to the endeffector and a proximal portion connected to the handle, wherein therigid link includes an angled surface between the distal portion and theproximal portion, wherein the method further includes the step ofengaging the tube to compress the rigid link along the angled surface asthe rigid link is pulled proximally by the handle, the tube engagementmoving the anvil face and the cartridge face relative to one another.

In another embodiment, a method of stapling an anatomical structure of apatient during a minimally invasive procedure is disclosed, where theanatomical structure has a first side and a second side. The methodincludes the steps of: providing an anvil that includes a first end, asecond end, and a face; positioning the anvil face on the first side ofan anatomical structure; providing a cartridge housing a plurality ofstaples, the cartridge including a first end, a second end, and a face,the face including a channel extending from the second end to the firstend, wherein the second end of the anvil is movably coupled to thesecond end of the cartridge; positioning the cartridge face on thesecond side of the anatomical structure; providing a blade having acutting surface and an elongated arm, the elongated arm extending atleast from the blade positionable near the second end of the cartridgeto the first end of the cartridge, the arm slidably engaged with thecartridge channel; providing a rigid link that movably couples the firstend of the anvil to the first end of the cartridge; moving the rigidlink causing at least a portion of one of the anvil and the cartridge tomove toward the other to clamp the anatomical structure between theanvil face and the cartridge face; and pulling the blade through theanatomical structure, simultaneously cutting and stapling the anatomicalstructure.

The elongated arm of the blade may substantially fill the cartridgechannel proximally from the blade as the blade is moved from the secondend to the first end. The blade may include a substantially I-shapedportion having a top portion and a bottom portion connected by a middleblade portion, the middle blade portion having a sharp cutting edge,wherein the anvil has a first opening near its first end and a secondopening near its second end. The method may further include the step ofreceiving top portion of the substantially I-shaped portion into thefirst opening before pulling the blade through the anatomical structureand removing the top portion of the substantially I-shaped portion fromthe second opening after pulling the blade through the anatomicalstructure. The rigid link may include a distal portion connected to theanvil and a proximal portion connected to a handle, wherein thecartridge includes a ramp adjacent to the distal portion of the rigidlink, wherein the method further includes the step of sliding the rigidlink against the ramp to urge the rigid link in the axial direction asthe rigid link slides. The rigid link may include a ramp surface thatcontacts the ramp as the rigid link slides. One or more of the methodsdisclosed herein may be useful for sleeve gastrectomy, vertical sleevegastrectomy or procedures involving a resection of the stomach.

In another embodiment, an end effector for use by a surgeon to staple ananatomical structure of a patient during a minimally invasive procedureis disclosed, where the anatomical structure has a first side and asecond side. The end effector includes an anvil that includes a firstend, a second end, and an anvil face that may be positionable on thefirst side of the anatomical structure, the anvil having a plurality ofanvil-side cord supports; a cartridge housing a plurality of staples andthat includes a first end, a second end, and a cartridge face that maybe positionable on the second side of the anatomical structure, thecartridge having a plurality of cartridge-side cord supports; and a linkthat movably couples the first end of the anvil to the first end of thecartridge, wherein the second end of the anvil is movably coupled to thesecond end of the cartridge, each of the anvil and the cartridge isinsertable through a trocar and the end effector may be remotelyoperable from outside the patient to move at least a portion of one ofthe anvil and the cartridge toward the other to clamp the end effectoron the anatomical structure. The plurality of anvil-side cord supportsmay have an opening facing away from the cartridge, and the plurality ofcartridge-side cord supports may have an opening facing away from theanvil. The plurality of anvil-side cord supports and the plurality ofcartridge-side cord supports may have an open tubular structure with asubstantially C-shaped cross-sectional shape. In one particularembodiment the plurality of anvil-side cord supports and the pluralityof cartridge-side cord supports have an open tubular structure with asubstantially C-shaped cross-sectional shape, the opening of the Cfacing away from the cartridge on the plurality of anvil-side cordsupports and the opening of the C facing away from the anvil on theplurality of cartridge-side cord supports.

The plurality of anvil-side cord supports and the plurality ofcartridge-side cord supports may have a hollow tubular structure and theend effector may include a buttress material, the buttress materialhaving a plurality of openings with a cord slidably positioned withinthe plurality of openings of the buttress material. In a preponderanceof the plurality of openings of the buttress material, the cord may beslidably positioned within at least one of the plurality of anvil-sidecord supports and the plurality of cartridge-side cord supports. Thecartridge-side cord supports may be mounted to the cartridge frame.

At least one of the anvil and the cartridge may include an elongatedslot wherein the end effector has a rigid link that movably couples thefirst end of the anvil to the first end of the cartridge, wherein therigid link is retained within the elongated slot such that the rigidlink is slidable along the elongated slot in a first direction butlimited in motion of the rigid link within the elongated slot in asecond direction.

In one embodiment, a surgical instrument to staple an anatomicalstructure of a patient is disclosed, where the anatomical structure hasa first side and a second side. The surgical instrument includes anelongated end effector having a length and a width, wherein the lengthis at least ten times the width, the length defining a longitudinaldirection, the longitudinal direction defining an axial directionsubstantially perpendicular to the longitudinal direction. The surgicalinstrument has an anvil that includes a first end, a second end, aplurality of anvil-side cord supports arranged from about the first endto about the second end, and an anvil face that may be positionable onthe first side of the anatomical structure. The surgical instrumentfurther includes a cartridge housing a plurality of staples and thatincludes a first end, a second end, a plurality of cartridge-side cordsupports arranged from about the first end to about the second end, anda cartridge face that may be positionable on the second side of theanatomical structure, wherein the second end of the anvil is movablycoupled to the second end of the cartridge. At least one of the anviland the cartridge includes an elongated slot having its direction ofelongation substantially along the longitudinal direction, and a rigidlink that movably couples the first end of the anvil to the first end ofthe cartridge, wherein the rigid link is retained within the elongatedslot such that the rigid link is slidable along the elongated slot butsubstantially limited in motion of the rigid link within the elongatedslot in the axial direction.

In one particular embodiment the plurality of anvil-side cord supportshave an opening facing substantially away from the cartridge, and theplurality of cartridge-side cord supports have an opening facingsubstantially away from the anvil. The plurality of anvil-side cordsupports and the plurality of cartridge-side cord supports may have anopen tubular structure with a substantially C-shaped cross-sectionalshape, where the opening of the C may be facing away from the cartridgeon the plurality of anvil-side cord supports and the opening of the Cmay be facing away from the anvil on the plurality of cartridge-sidecord supports.

The plurality of anvil-side cord supports and the plurality ofcartridge-side cord supports may have a hollow tubular structure andwherein the end effector may include a buttress material, the buttressmaterial having a plurality of openings with a cord slidably positionedwithin the plurality of openings. In a preponderance of the plurality ofopenings of the buttress material, the cord may be slidably positionedwithin at least one of the plurality of anvil-side cord supports and theplurality of cartridge-side cord supports. The plurality ofcartridge-side cord supports may be mounted to the cartridge frame. Thebuttress material may include an adhesive that removably adheres thebuttress material to one of the anvil face and the cartridge face.

In still a further embodiment, a method of using a buttress materialwith an end effector includes the steps of: providing an end effectorhaving an anvil that includes a first end, a second end, and an anvilface, a cartridge housing a plurality of staples and that includes afirst end, a second end, and a cartridge face, and a rigid link thatmovably couples the first end of the anvil to the first end of thecartridge, wherein the second end of the anvil is movably coupled to thesecond end of the cartridge; providing a buttress material; moving therigid link to open the anvil face away from the cartridge face;attaching the buttress material to at least one of the anvil face andthe cartridge face; moving the rigid link to close the anvil facetowards the cartridge after attaching the buttress material; driving theplurality of staples from the cartridge, through the buttress material,and towards the anvil to form the staples; moving the rigid link to openthe anvil face away from the cartridge face after driving the staples;and removing the buttress material from the end effector. The buttressmaterial may be formed from a bio-absorbable material. The buttressmaterial may be attached to at least one of the anvil face and thecartridge face using an adhesive. The anvil may include a plurality ofanvil-side cord supports arranged from about the first end to about thesecond end, the cartridge including a plurality of cartridge-side cordsupports arranged from about the first end to about the second end, andthe buttress material including a plurality of openings, with a cordslidably positioned within the plurality of openings. The method mayfurther include one or more of the steps of: sliding the cord from thebuttress material into a preponderance of the cord supports whenattaching the buttress material to at least one of the anvil face andthe cartridge face, and sliding the cord from the buttress material outof the preponderance of the cord supports when removing the buttressmaterial from the end effector; tensioning the cord to align thebuttress material with the end effector; and pulling the cord todisengage the buttress material from the end effector by sliding thecord out of the plurality of cord supports and out of the plurality ofopenings of the buttress material.

In another embodiment, a device is disclosed that includes a first jawhaving an anvil that includes a first end, a second end, and an anvilface, the anvil having a plurality of anvil-side cord supports; a secondjaw having a cartridge housing a plurality of staples and that includesa first end, a second end, and a cartridge face, the cartridge having aplurality of cartridge-side cord supports; a first coupling that couplesthe first end of the first jaw to the first end of the second jaw; and asecond coupling that movably couples the second end of the first jaw tothe second end of the second jaw, wherein the second coupling includes arigid link that is movably coupled to the first and second jaws. Anouter tube may extend from the first jaw and the second jaw to anactuator, wherein the actuator moves the outer tube from a firstposition to a second position, wherein the first position of the tubeallows the rigid link to maintain the jaws in an open position, and thesecond position of the tube moves the rigid link to move the first jawtowards the second jaw. The second jaw may have a longitudinal axis,wherein the first coupling includes a pin that rotatably couples thefirst jaw to the second jaw, wherein the rotation about the pin istransverse to the longitudinal axis. The pin that rotatably couples thefirst jaw to the second jaw may be slidably received within a slot in atleast one of the first jaw or the second jaw. In one embodiment at leastone of the first jaw or the second jaw slidably receives the rigid linkwithin a slot as the first jaw is moved toward the second jaw. The rigidlink may be coupled to the first jaw using a slot that allows motion ofthe rigid link in a first direction but limits motion of the rigid linkin a direction perpendicular to the first direction.

In another embodiment, an end effector useful to staple an anatomicalstructure is disclosed, the anatomical structure having a first side anda second side. The end effector includes: an anvil that includes a firstend, a second end, and an anvil face that may be positionable on thefirst side of the anatomical structure, the anvil face including aplurality of rows of staple forming pockets, where a first row of theplurality of rows of staple forming pockets has a first pocket depth andthe second row of the plurality of rows of staple forming pockets has asecond pocket depth, where the first pocket depth is different from thesecond pocket depth; a cartridge housing a plurality of staples and thatincludes a first end, a second end, and a cartridge face that may bepositionable on the second side of the anatomical structure; and astaple driver ramp and tissue cutting assembly having a staple driverramp that moves from the first end of the cartridge to the second end ofthe cartridge and drives staples from the cartridge towards the anvil toform the staples, the staple driver ramp and tissue cutting assemblyfurther including a blade that cuts the anatomical structure after thestaples have been formed with at least a portion of one of the anvil andthe cartridge being movable toward the other to clamp the end effectoron the anatomical structure.

The cartridge face may include a channel extending from about the secondend to about the first end, the channel defining the path of a cuttingblade, wherein the pocket depth of the first row of the plurality ofrows of staple forming pockets has a first pocket depth that isshallower than the pocket depth of the second row of the plurality ofrows, wherein the first row of the plurality of rows of staple formingpockets is closer to the slot than the second row of the plurality ofrows of staple forming pockets. The anvil may have an anvil lengthextending from about the first end of the anvil to about the second endof the anvil, the plurality of rows of the plurality of staple formingpockets extending along the anvil length, wherein in at least one row ofthe plurality of rows of the plurality of staple forming pockets, afirst pocket depth at a first location along the length is differentfrom a second pocket depth at a second location along the length. Theanvil may include at least 3 rows of the plurality of staple formingpockets, each one of the at least three rows having the plurality ofpocket depths different from the other two of the at least three rows.For example, the row of staple forming pockets closest to the channelmay be shallower than row of staple forming pockets farthest from thechannel. In one embodiment, the rows of staple forming pockets aresubstantially circular.

The plurality of staples in a first row of the plurality of rows ofstaples may be manufactured from a first material and the plurality ofstaples in a second row of the plurality of rows of staples may bemanufactured from a second material, wherein the first material isdifferent from the second material. The anvil has an anvil lengthextending from about the first end of the anvil to about the second endof the anvil, wherein in at least one row of the plurality of rows ofthe plurality of staple forming pockets, a first pocket depth at a firstlocation along the length is different from a second pocket depth at asecond location along the length. The pocket depth may vary continuouslyalong the anvil length. In one embodiment, in at least one row of theplurality of rows of staple forming pockets, the pocket depth has afirst depth for a first portion of the length of the row and a seconddepth for a second portion of the length of the row. In anotherembodiment, in at least one row of the plurality of rows of stapleforming pockets the pocket depth has a first depth for a first portionof the length of the row and a second depth, deeper than the firstdepth, for a second portion of the length of the row adjacent the firstportion of the length of the row and a third depth for a third portionof the length of the row, shallower than the second depth, the thirdportion of the length of the row adjacent the second portion of thelength of the row. The rows of staple forming pockets may besubstantially circular such as for use in a circular stapler useful forbowel resection, may be linear for a linear cutter, or may be anotherdesired shape. In at least one row of the plurality of rows of stapleforming pockets in one embodiment, the pocket depth variation along thelength of a first row of the plurality of rows varies in pocket depth ata different scale or rate than a second row of the plurality of rows.

In another embodiment, an end effector is disclosed for stapling ananatomical structure, the anatomical structure having a first side and asecond side. The end effector includes: an anvil that includes a firstend, a second end, and an anvil face that may be positionable on thefirst side of the anatomical structure, the anvil face including aplurality of rows of staple forming pockets, wherein a first row of theplurality of rows of staple forming pockets has a first pocket depth andthe second row of the plurality of rows of staple forming pockets has asecond pocket depth, wherein the first pocket depth is different fromthe second pocket depth; a cartridge housing a plurality of staples andthat includes a first end, a second end, and a cartridge face that maybe positionable on the second side of the anatomical structure; and astaple driver ramp and tissue cutting assembly, wherein the stapledriver ramp moves from the first end of the cartridge to the second endof the cartridge and drives staples from the cartridge towards the anvilto form the staples, the staple driver ramp and tissue cutting assemblyfurther including a blade that cuts the anatomical structure after thestaples have been formed, with at least a portion of one of the anviland the cartridge being movable toward the other to clamp the endeffector on the anatomical structure, wherein a first row of theplurality of rows of staple forming pockets has a first pocket shape andthe second row of the plurality of rows of staple forming pockets has asecond pocket shape, wherein the first pocket shape is different fromthe second pocket shape. The first row of the plurality of rows ofstaple forming pockets may produce bow-tie shaped staples and the secondrow of the plurality of rows of staple forming pockets may producerectangular shaped staples after forming, in one example. A first row ofthe plurality of rows of staples may be manufactured from a firstmaterial and the plurality of staples in a second row of the pluralityof rows of staples may be manufactured from a second material, whereinthe first material is different from the second material in anotherexample. For example, the first material may contain greater than 95% byweight of Titanium and the second material may be an alloy of less than95% by weight of titanium alloyed with aluminum. In another example, thefirst material may contain greater than 96% by weight of titanium andthe second material may be an alloy of less than 96% by weight oftitanium alloyed with aluminum and vanadium. In another example, theplurality of staples in a first location along the length may bemanufactured from a material greater than 95% by weight of titanium andthe plurality of staples in a second location along the length may bemanufactured from an alloy of less than 95% by weight titanium alloyedwith aluminum. In another embodiment, the row of the plurality ofstaples closer to the channel has staples with less springback than therow of the plurality of staples further from the channel.

In another exemplary embodiment, an anvil that includes a first end, asecond end, and an anvil face that may be positionable on the first sideof an anatomical structure. A cartridge housing a plurality of staplesand that includes a first end, a second end, a cartridge lengthextending from about the first end of the cartridge to about the secondend of the cartridge, and a cartridge face that may be positionable onthe second side of the anatomical structure. The cartridge may include aplurality of rows of a plurality of staples, wherein the plurality ofstaples in a first portion of a first row of the plurality of rows ofstaples may be manufactured from a first material and the plurality ofstaples in a second portion of the first row of the plurality of rows ofstaples may be manufactured from a second material, wherein the firstmaterial is different from the second material. A staple driver ramp andtissue cutting assembly may have a staple driver ramp that moves fromthe first end of the cartridge to the second end of the cartridge anddrives staples from the cartridge towards the anvil to form the staples.The staple driver ramp and tissue cutting assembly may further include ablade that cuts the anatomical structure after the staples have beenformed, with at least a portion of one of the anvil and the cartridgebeing movable toward the other to clamp the end effector on theanatomical structure. The first material may contain greater than 96% byweight of titanium, for example, and the second material may be an alloyof less than 96% by weight of titanium alloyed with aluminum andvanadium.

In another embodiment, an end effector is disclosed that is useful tostaple an anatomical structure during a surgical procedure, theanatomical structure having a first side and a second side. The endeffector includes an anvil that has a first end, a second end, and ananvil face that may be positionable on the first side of the anatomicalstructure, the anvil face including a plurality of rows of stapleforming pockets, wherein a first row of the plurality of rows of stapleforming pockets has a first pocket shape and a second row of theplurality of rows of staple forming pockets has a second pocket shape,wherein the first pocket shape is different from the second pocketshape. A cartridge housing a plurality of staples and that includes afirst end, a second end, and a cartridge face that may be positionableon the second side of the anatomical structure is also disclosed. Astaple driver ramp and tissue cutting assembly is disclosed as having astaple driver ramp that moves from the first end of the cartridge to thesecond end of the cartridge and drives staples from the cartridgetowards the anvil to form the staples, the staple driver ramp and tissuecutting assembly further including a blade that cuts the anatomicalstructure after the staples have been formed, with at least a portion ofone of the anvil and the cartridge being movable toward the other toclamp the end effector on the anatomical structure. The first row of theplurality of rows of staple forming pockets may produce bow-tie shapedstaples after forming and the second row of the plurality of rows ofstaple forming pockets may produce rectangular shaped staples afterforming, for example. In at least one row of the plurality of rows ofthe plurality of staple forming pockets, a first pocket shape at a firstlocation along the length is different from a second pocket shape at asecond location along the length in another example. A first row of theplurality of rows of staple forming pockets may produce bow-tie shapedstaples after forming and a second row of the plurality of rows ofstaple forming pockets may produce rectangular shaped staples afterforming in another example. Also, the plurality of staples in a firstportion of the first row of the plurality of rows of staples may bemanufactured from a first material and the plurality of staples in asecond portion of the first row of the plurality of rows of staples maybe manufactured from a second material, wherein the first material isdifferent from the second material.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will be more readily understood from a detaileddescription of some sample embodiments taken in conjunction with thefollowing figures:

FIG. 1 depicts the anatomy of a stomach;

FIG. 2A depicts a perspective view of a stapling device, shown in anopen position, having an end effector, an elongated tube, and a handleportion in accordance with one embodiment;

FIG. 2B depicts a perspective view of the stapling device of FIG. 2A,shown in a closed position, in accordance with one embodiment;

FIG. 3A is a partially exploded perspective view of the stapling deviceshown in FIGS. 2A and 2B;

FIG. 3B is an exploded perspective view of the stapling device shown inFIGS. 2A and 2B;

FIG. 4 depicts an axial cross-sectional view of the end effector shownin FIG. 2B, taken along section A-A, showing the relationship between ablade, an anvil assembly, and a cartridge assembly of the end effector;

FIG. 5A depicts a cross-sectional side view of the handle portion, takenalong section B-B, of the stapling device shown in FIG. 2B in a firstposition;

FIG. 5B depicts a cross-sectional side view of the handle portion, takenalong section B-B, of the stapling device shown in FIG. 2B in a secondposition;

FIG. 5C depicts a cross-sectional side view of the handle portion, takenalong section B-B, of the stapling device shown in FIG. 2B in a thirdposition;

FIG. 5D depicts a cross-sectional side view of the handle portion, takenalong section B-B, of the stapling device shown in FIG. 2B in a fourthposition;

FIG. 5E depicts a cross-sectional side view of the handle portion, takenalong section B-B, of the stapling device shown in FIG. 2B in a fifthposition;

FIG. 6 is a partial perspective view of a blade assembly and a drivemechanism for a surgical device according to one embodiment;

FIG. 7 depicts a cross-sectional view of the elongated support tubeshown in FIG. 2B, taken along section C-C, illustrating the relationshipbetween the blade assembly and the drive mechanism shown in FIG. 6,according to one embodiment;

FIG. 8 depicts a partial cross-sectional side view of the handle portionshown in FIG. 2B illustrating the relationship between the bladeassembly and the drive mechanism, shown in FIG. 6, according to oneembodiment;

FIG. 9 depicts a side view of a proximal end of the end effector shownin FIG. 2A;

FIG. 10 depicts a partial bottom plan view of an anvil assemblyaccording to one embodiment;

FIG. 11 depicts a perspective view of a stapling device, shown in anopen position, having an end effector, an elongated tube, a handleportion, and a motor in accordance with an alternate embodiment;

FIG. 12 is a partially exploded perspective view of the end effector,elongated tube, and handle portion of the stapling device shown in FIG.11;

FIG. 13 is a partially exploded perspective view of the motor of thestapling device shown in FIG. 11;

FIG. 14A depicts a side view of the stapling device of FIG. 11 shown inan open position;

FIG. 14B depicts a side view of the stapling device of FIG. 11 shown ina closed position;

FIG. 15 depicts a side cross-sectional view, taken along section D-D, ofthe handle portion and the motor shown in FIG. 14A;

FIG. 16 depicts a side view of the end effector shown in FIG. 14A;

FIG. 17 depicts a side cross-sectional view, taken along section E-E, ofthe handle portion and the motor shown in FIG. 14B;

FIG. 18 depicts a side view of the end effector shown in FIG. 14B;

FIG. 19 is a sectioned side view of a blade assembly and a driveassembly for a stapling device according to one embodiment;

FIG. 20 is a sectioned side view of a blade assembly and a driveassembly for a stapling device according to an alternate embodiment;

FIG. 21 is a sectioned side view of a blade assembly and a driveassembly for a stapling device according to an alternate embodiment;

FIG. 22 is a partial perspective view of an anvil assembly having ananvil chamfer according to one embodiment;

FIG. 23 is a perspective view of a motor controller according to oneembodiment;

FIG. 24 is an exploded perspective view of the motor controller shown inFIG. 23;

FIG. 25 is a partial cross-sectional perspective view of an end effectorfor a stapling device showing a blade assembly in relationship with acartridge assembly having a plurality of drivers and staples;

FIG. 26A is a side cross-sectional view of an end effector for astapling device, including an anvil assembly and a cartridge assembly,having a plurality of staple drivers having variable heights combinedwith a plurality of staples having variable heights according to oneembodiment;

FIG. 26B is a side cross-sectional view of an end effector for astapling device, including an anvil assembly and a cartridge assembly,having a plurality of staple drivers having variable heights combinedwith a plurality of staples having variable heights according to analternate embodiment;

FIG. 26C is a cross-sectional view of an end effector for a staplingdevice, including an anvil assembly and a cartridge assembly, having aplurality of staple drivers with a first height associated with aplurality of staples having a first height and a plurality of drivershaving a second height associated with a plurality of staples having asecond height according to one embodiment;

FIG. 26D is a cross-sectional view of an end effector for a staplingdevice, including an anvil assembly and a cartridge assembly, having aplurality of staple drivers having a uniform height combined with aplurality of staples having variable heights according to oneembodiment;

FIG. 26E is a cross-sectional view of an end effector for a staplingdevice, including an anvil assembly having an angled anvil plate and acartridge assembly, the stapling device having a plurality of stapledrivers with a uniform height and a plurality of staples having auniform height;

FIG. 27 is a flow chart depicting a method of operating a staplingdevice according to one embodiment;

FIG. 28 is a partial flow chart depicting a method of operating astapling device according to one embodiment;

FIG. 29 is a partial flow chart depicting the method of operating astapling device continuing the method of FIG. 28;

FIG. 30 is a partial flow chart depicting the method of operating astapling device continuing the method of FIG. 29;

FIG. 31 depicts a perspective view of a stapling device, shown in anopen position, having an end effector, an elongated tube, a handleportion, and a motor in accordance with an one embodiment;

FIG. 32 depicts a partial exploded perspective view of the staplingdevice of FIG. 31 shown with a buttress;

FIG. 33A is a side view of the stapling device of FIG. 31 shown in anopen position;

FIG. 33B is a side view of the stapling device of FIG. 31 shown in aclosed position;

FIG. 34A is a top view of the buttress shown in FIG. 32;

FIG. 34B is a partial perspective view of the buttress shown in FIG. 32;

FIG. 35A depicts a bottom plan view of an anvil assembly of the endeffector shown in FIG. 31;

FIG. 35B depicts a bottom plan view of the anvil assembly, shown in FIG.31, with the buttress of FIG. 32 attached, according to one embodiment;

FIG. 36 depicts a perspective view of the stapling device of FIG. 31,shown with the buttress of FIG. 32 attached, according to oneembodiment.

FIG. 37 depicts a partial exploded perspective view of a staplingdevice, shown in an open position, having an end effector, an elongatedtube, a handle portion, and an adhesive-type buttress in accordance withone embodiment;

FIG. 38A is a cross-sectional view of the adhesive-type buttress, takenalong section F-F, shown in FIG. 37;

FIG. 38B is a perspective view of the adhesive-type buttress, shown inFIG. 37, with a removable portion removed;

FIG. 38C is a front view of the adhesive-type buttress shown in FIG.38B;

FIG. 38D depicts a side view of the end-effector of FIG. 37 shown withthe adhesive-type buttress attached to the end effector according to oneembodiment;

FIG. 38E depicts a front view of a stomach shown resected with a stapleline, coupled with a buttress material, forming a sleeve gastrectomy.

FIG. 39A is a bottom view of an anvil assembly for an end effector of astapling device in accordance with one embodiment;

FIG. 39B is a cross-sectional view of the anvil assembly illustrated inFIG. 39A, taken along section G-G, in accordance with one embodiment;

FIG. 39C is a cross-sectional view of the anvil assembly illustrated inFIG. 39A, taken along section H-H, in accordance with one embodiment;

FIG. 40 is a side cross-sectional view of an end effector having ananvil plate with with varying pocket depths according to one embodiment;

FIG. 41 is an axial cross-sectional view of an anvil assembly with ananvil plate, shown with a plurality of staples, in accordance with oneembodiment;

FIG. 42A is a side view of a staple formed by the anvil plate of FIG.40;

FIG. 42B is a side view of a staple formed by the anvil of FIG. 40;

FIG. 42C is a side view of a staple formed by the anvil of FIG. 40;

FIG. 43A is a partial bottom plan view of an anvil assembly having aplurality of anvil pockets in accordance with one embodiment;

FIG. 43B is a more detailed view of a section of the anvil assemblyshown in FIG. 43A;

FIG. 43C is an partial bottom plan view of an anvil for an end effectorin having a plurality of anvil pockets in accordance with an alternateembodiment;

FIG. 44 is a side view of a staple formed by an anvil assembly inaccordance with one embodiment;

FIG. 45 is a top view of a staple formed by an anvil assembly inaccordance with an alternate embodiment;

FIG. 46 is a perspective view of a staple formed by an anvil assembly inaccordance with an alternate embodiment; and

FIG. 47 is a perspective view of a stapler in accordance with oneembodiment having a circular anvil.

DETAILED DESCRIPTION

Various non-limiting embodiments of the present disclosure will now bedescribed to provide an overall understanding of the principles of thestructure, function, and use of the apparatuses, systems, methods, andprocesses disclosed herein. One or more examples of these non-limitingembodiments are illustrated in the accompanying drawings. Those ofordinary skill in the art will understand that systems and methodsspecifically described herein and illustrated in the accompanyingdrawings are non-limiting embodiments. The features illustrated ordescribed in connection with one non-limiting embodiment may be combinedwith the features of other non-limiting embodiments. Such modificationsand variations are intended to be included within the scope of thepresent disclosure. Reference throughout the specification to “variousembodiments,” “some embodiments,” “one embodiment,” “some exampleembodiments,” “one example embodiment,” or “an embodiment” means that aparticular feature, structure, or characteristic described in connectionwith any embodiment is included in at least one embodiment. Thus,appearances of the phrases “in various embodiments,” “in someembodiments,” “in one embodiment,” “some example embodiments,” “oneexample embodiment, or “in an embodiment” in places throughout thespecification are not necessarily all referring to the same embodiment.Furthermore, the particular features, structures or characteristics maybe combined in any suitable manner in one or more embodiments. Describedherein are example embodiments of apparatuses, systems, and methods forsurgical staplers. In one example embodiment, an end effector and/or anendocutter stapling device (collectively referred to as “devices”herein) is disclosed for forming a resection line during resection of anorgan, tissue, or other anatomical structure. In some embodiments, thedevices may be used during minimally invasive surgical procedures. Thisapplication is related to U.S. patent application Ser. No. 15/129,385,which is hereby incorporated herein by reference in its entirety.

Surgical staplers in accordance with embodiments described herein caninclude a handle, an actuator, and an end effector including a clampingmechanism. The clamping mechanism can include a cartridge and an anvil.During operation, the surgeon can clamp two members (e.g., the anvil andthe cartridge) on the organ and compress the organ therebetween. Oncethe organ has been compressed, the surgeon can use the stapler to driveor fire staples through the organ. In one embodiment, with desirablecompression and alignment of the clamping mechanism, a plurality ofB-shaped staples can be formed. In some embodiments, the stapling devicecan be fired multiple times using multiple cartridges, or in analternate embodiment a single cartridge can be used with a single firingto complete resection of an organ. It may be advantageous to reduce thenumber of firings and cartridges required as the expense of a procedurecan increase with the use of cartridges and with a longer procedure thatcan be associated with multiple stapler firings. It may also beadvantageous to provide for single cartridge stapling and/or resectionof an organ to reduce the time a patient is in surgery, which canimprove clinical outcomes. For example, resecting a portion of thestomach in accordance with a sleeve gastrectomy procedure using a singlecartridge and stapler firing may improve patient outcomes and reducecomplications that can be associated with such procedures.

The integrity of a staple line can depend, in part, on the properformation of B-shaped staples when such a staple configuration isdesirable. Providing a single cartridge and single firing staplingdevice may improve the quality of staple formation over a device orsystem using multiple cartridges to complete the same procedure. Forexample, when using an end effector multiple times to staple and resecttissue the previously deployed staples may be contacted by the newstaples and/or cutting knife in subsequent applications. Providing asingle cartridge and staple firing may help insure that the staple line,and shape of the staples, is consistent.

A single cartridge and single firing stapling device may also providecompression benefits relative to a device and system requiring the useof multiple cartridges. It may be advantageous to provide a singlefiring stapling device that provide for desirable compression along thelength of the tissue to be resected while also providing for a singlestaple line with properly formed staples. A B-shaped staple is thestandard of care for gastrointestinal, vascular, pulmonary, and hepaticapplications of surgical tissue fastening devices. Alignment in each ofthe X, Y, and Z axes of the clamping mechanism with itself (e.g.,alignment of the anvil with the cartridge) on each side of the organ mayimprove staple delivery and formation. It will be appreciated that anysuitable structure or mechanism may be incorporated into the staplingdevices described herein to provide for such alignment.

Embodiments of stapling devices described herein may include multiplerows of staples such that there is less chance of leaking of lumenalcontents between each of the staples and the staple rows. For example, astapling device may have from two to six rows of staples, where thestaple rows can be bisected by a knife or blade configured to passbetween the rows to resect stapled tissue. In one embodiment, the staplerows can be spaced apart and/or staggered to reduce the likelihood ofleakage.

Embodiments of stapling devices can include an anvil and a cartridge,where the cartridge can include recesses retaining a plurality ofstaples. The staples can be retained above one or more staple driversthat, during operation, can urge each of the plurality of staples upwardthrough tissue into the face of the anvil. The anvil, which can includepockets having any suitable size, number, and dimensions, can cooperatewith the cartridge drivers to form, for example, a B-shape withintissue. The pockets of the anvil, in one embodiment, can be sized toprovide a desirable closed staple height that can be determined by thegap between the anvil and cartridge, the depth of the pocket and theheight of the staple, and/or the staple driver and the driver mechanism.

During stapling, it may be advantageous to provide a support or buttressmaterial through which the staples can be deployed. The buttress orsupport material may help distribute the pressure of multiple rows ofstaples, to improve the purchase of the staples in tissue, or tomaintain the integrity of a staple line. For example, a biodegradablematerial can be provided on the faces of the anvil and/or cartridgethrough which the staples can be deployed during use. This buttressmaterial, retaining the staples, can then be cut by a blade or knifeand, in one embodiment, can be left within a patient. Any suitablesupport or buttress material, such as those composed of polymers (bothpermanent and bioabsorbable) as well as biologic films can be used inaccordance with embodiments described herein. These materials can bereversibly coupled to the anvil, the cartridge, or both.

Methods of attaching the buttress or support material to the anvil orcartridge can include adhesives, such as hydrogel polymers, where thebuttress can be pulled away from the end effector after it has beensecured with staples to tissue. The end effector may also includemechanical structures or elements to retain the buttress, such asprojections or the like. In one embodiment, the anvil and/or cartridgecan include a plurality of spaced apart projections, the buttressmaterial can define a plurality of apertures, and a cord or suture canbe used to threadedly secure the buttress material with the projectionsof the anvil and/or cartridge.

Embodiments of stapling devices described herein, in accordance with alaparoscopic approach, can include inserting the end effector of thestapler through a trocar to perform the surgical procedure. By way ofexample, minimally invasive surgical procedures may include alaparoscopic vertical sleeve gastrectomy. Because the spatialenvironment for such procedures is limited, surgical stapling devices inaccordance with embodiments described herein may have a relative lowprofile. Minimally invasive devices in the prior art are generally long(e.g., 35 mm to 60 mm) and thin (e.g., 5 mm to 15 mm diameter) devices.This long and thin configuration may be necessary to fit through thetrocar into the body cavity. The limited size can present a mechanicalissue as B-shaped staple formation typically requires a pressure ofabout 100 psi. Under these pressures, small, less rigid, staplers maydeform and thus prevent proper B-shaped staple formation.

Prior art devices used in minimally invasive surgical procedures oftenhave a fixed hinge at a proximal end. This hinge allows the anvil andcartridge to separate into a V-shaped configuration. Once separated, thesurgeon may place the open anvil and cartridge around the organ and thencollapse the V onto the organ. However, as the length of the anvil andcartridge increase, it may be more difficult to maintain alignmentbetween the anvil and cartridge across the length of the tissue. Pooralignment with such designs can be exacerbated at the most distant endsof such devices can be deflected because of the forces necessary tocompress the tissue. Because of this deflection, the length of currentV-shaped staplers for minimally invasive procedures is limited. As aresult of this limitation, the anvil and the cartridge arecorrespondingly limited in length. This limitation on length requires,for larger organs like the stomach, multiple staple reloads and firingsto complete a procedure such as a sleeve gastrectomy. Each reload mayrequire the surgeon to withdraw the stapler from the trocar, reload thecartridge, reinsert, and then reposition the stapler on the organ. Suchsystems may require more surgical time, may be more costly, may have anincreased likelihood of resulting in an adverse patient event, and mayresult in a staple line having less integrity.

The examples discussed herein are examples only and are provided toassist in the explanation of the apparatuses, devices, systems andmethods described herein. None of the features or components shown inthe drawings or discussed below should be taken as mandatory for anyspecific implementation of any of these the apparatuses, devices,systems or methods unless specifically designated as mandatory. For easeof reading and clarity, certain components, modules, or methods may bedescribed solely in connection with a specific figure. Any failure tospecifically describe a combination or sub-combination of componentsshould not be understood as an indication that any combination orsub-combination is not possible. Also, for any methods described,regardless of whether the method is described in conjunction with a flowdiagram, it should be understood that unless otherwise specified orrequired by context, any explicit or implicit ordering of stepsperformed in the execution of a method does not imply that those stepsmust be performed in the order presented but instead may be performed ina different order or in parallel.

Example embodiments described herein can be used, for example, in asleeve gastrectomy procedure or resection of the stomach. It will beappreciated, however, that the devices may be used in other proceduresinvolving other anatomical structures. For example, the devices may beused in a parencymal resection, lung volume reduction surgery, or otherprocedures involving the lung. Further, embodiments described herein maybe useful in an anatomic resection, such as, a lobectomy, a non-anatomicparencymal resection, or other procedures involving the liver, or in apartial nephrectomy, total nephrectomy, or other procedures involvingthe kidney.

Referring now to FIG. 1, shown are the anatomy of the stomach 10 and anexample resection line 12 for a vertical sleeve gastrectomy. The stomach10 generally includes an inferior end 14, a superior end 16, an anteriorside 18, and a posterior side 20. A gastroesophageal junction 22 opensinto the stomach 10 and is a common landmark in bariatric surgeries. Afundus 24 and the section of the stomach 10 defined by a greatercurvature 26 are generally the parts of the stomach 10 removed during avertical sleeve gastrectomy. The remaining pouch or sleeve may begenerally defined by a lesser curvature 28 and the resection line 12,which presents a stomach with a significantly reduced volume. Thedesired location of the resection line 12 may be about 0.5 cm to about 2cm away from the gastroesophageal junction 22 and about 2 cm to about 10cm away from a pylorus 30. In accordance with embodiments describedherein, endocutter stapling devices may be utilized to form highquality, consistent resection lines during a vertical sleevegastrectomy. Embodiments of the devices may be advantageous because theymay be easily positionable laparoscopically, can accommodate differentthicknesses of tissue along the resection line length, can be capable ofproviding uniform compressive pressure on the tissue along the resectionline, and can enable a low staple firing force.

FIG. 2A depicts a perspective view of a stapling device 100 including anend effector 121, a support tube 140, and a handle portion 123, shown inan open position. FIG. 2B depicts a perspective view of the staplingdevice 100 shown in a closed position.

FIGS. 3A and 3B depict an exploded perspective view of the staplingdevice 100 illustrated in accordance with at least one embodiment. Theend effector 121 of the stapling device 100 can include an anvilassembly 101 and a cartridge assembly 103. The anvil assembly 101 caninclude an anvil frame 102 and an anvil plate 112. The anvil plate 112may be welded to the anvil frame 102, or may be otherwise attached tothe anvil frame 102 or end effector 121 such as by gluing, brazing,sintering, machining, 3D printing or the like. The anvil assembly 101can include a longitudinal axis along which the anvil frame 102 and theanvil plate 112 are oriented. The anvil plate 112 can define an anvilplate channel 137 aligned with the longitudinal axis that can be sizedto receive a blade 107 associated with a blade assembly 108. Asillustrated in FIG. 4, the anvil frame 102 and the anvil plate 112 cancooperate to define an anvil blade channel 139 that can be sized toaccept a top portion 228 of the blade 107. During operation, the anvilblade channel 139 can guide the blade 107 as it moves, for example, froma distal first position to a proximal second position within the anvilplate channel 137. In an alternate embodiment, the blade 107 cantransition from a proximal first position to a distal second position.Because the distal end of the end effector 121 is coupled in certainembodiments, rather than open, it permits the ability to initiallyposition the blade 107 at the distal end of the end effector prior touse or cutting. Such a position may be advantageous because the blade107 associated with the blade assembly 108 can be pulled, rather thanpushed, to prevent buckling. Providing a blade assembly 108 with anelongate beam 226 (FIG. 6) may be beneficial because, as the beam 226 iswithin the channels of the anvil and the cartridge it can prevent thecartridge from deflecting into the cavity of the channel. Suchdeflection into the channel may cause staples to be malformed. I-beamportions of the blade may correct for the deflection of the anvil andcartridge structural members that can happen during loading to enablethe proper gap for staple formation to be achieved.

Referring to FIGS. 3A and 3B, the anvil plate 112 can be, for example,from 20 cm to 26 cm in length, from 10 cm to 30 cm in length, from 5 cmto 32 cm in length, from 21 cm to 24 cm in length, or any other suitablelength. In one embodiment, the length of the anvil plate 112 is sizedsuch that it can traverse the length of an organ, such as the stomach,for use in a sleeve gastrectomy procedure. For example, the anvil plate112 can be 23 cm in length such that it can be used in combination withthe cartridge assembly 103 to provide a staple line in accordance with asingle firing, single cartridge sleeve gastrectomy procedure.

The cartridge assembly 103 can include a cartridge frame 116 that canretain a cartridge plate 114 and a cartridge 110. The cartridge plate114 may be welded to the cartridge frame 116, or may be otherwiseattached to the cartridge frame 116 or end effector 121 such as bygluing, brazing, sintering, machining, 3D printing or the like. Thecartridge assembly 103 can include a longitudinal axis along which thecartridge frame 116 and cartridge plate 114 can be oriented. Thecartridge plate 114 can define a cartridge channel 143 aligned with thelongitudinal axis that can be sized to receive the blade 107 associatedwith the blade assembly 108. As illustrated in FIG. 4, the cartridgeframe 116 and the cartridge plate 114 can cooperate to define acartridge blade channel 141 that can be sized to accept a bottom portion230 of the blade 107. During operation, the cartridge blade channel 141can guide the blade 107 as it moves, for example, from a distal firstposition to a proximal second position within the cartridge channel 143.In an alternate embodiment, the blade 107 can transition from a proximalfirst position to a distal second position. In alternate embodiment, thecartridge blade channel 141, or associated channels, can be curvilinearor have any other suitable configuration.

Referring to FIGS. 3A and 3B, the cartridge 110 can be attached to thecartridge frame 116 by a first cartridge pin 136 at a first end and asecond cartridge pin 118 at a second end or, alternately, the cartridge110 can be attached to the cartridge frame 116 via snap fit, gluing, orother attachment methods. The cartridge 110 can be, for example, from 20cm to 26 cm in length, from 10 cm to 30 cm in length, from 5 cm to 32 cmin length, from 21 cm to 24 cm in length, or any other suitable length.In one embodiment, the length of the cartridge 110 is sized such that itcan traverse the length of an organ, such as the stomach, for use in asleeve gastrectomy procedure. For example, the cartridge 110 can be 23cm in length such that it can be used in combination with the anvilassembly 101 to provide a staple line in accordance with a singlefiring, single cartridge sleeve gastrectomy procedure.

The end effector 121 can include a master link 106 that can be used totransition the end effector 121 from a closed position (see, forexample, FIG. 2B), to an open position (FIG. 2A), back to a closedposition. The master link 106 can be attached to a first end of theanvil frame 102, which may be a proximal end of the anvil frame 102, bya first master link pin 104 such that the first master link pin 104pivotally and slidably engages a master link slot 105 defined by theanvil frame 102. The master link slot 105 can be a channel parallel tothe longitudinal axis of the anvil frame 102, or the master link slot105 can be angled up or down, or otherwise offset relative to thelongitudinal axis of the anvil frame. In certain embodiments, the masterlink slot 105 can be angled or offset to achieve more (angled away from)or less (angled toward) gap between the anvil assembly 101 and thecartridge assembly 103. In certain embodiments, where the master linkslot 105 is angled or offset, the master link 106 can be configured tostop at any point along the master link slot 105 to change the gap andthus the angle of the anvil assembly 101 relative to the cartridgeassembly 103. Angling the master link slot 105 may also improve closingefficiency for the end effector 121.

A second master link pin 138 can be used to pivotally couple the masterlink 106 to a platform 142 as will be described further herein below. Inthe embodiment illustrated in FIGS. 3A and 3B, the cartridge frame 116can be insertable at its proximal end into a support tube 140, therebyaligning and connecting the end effector 121 of the stapling device 100to the handle portion 123 of the stapling device 100.

The support tube 140 can be an elongated member, having a proximal endand a distal end, that can be configured to extend through a trocar (notshown) such that the end effector 121 of the stapling device 100 canaccess the organ of a patient. The support tube 140 can be any suitablelength such as, for example, from 50 mm to 350 mm, from 100 mm to 350mm, from 100 mm to 200 mm, from 150 mm to 300 mm, or 100 mm. The supporttube 140 can have an outer diameter from 5 mm to 22 mm and can have awall thickness from 0.25 mm to 1.5 mm, for example.

The support tube 140 can be unitarily formed with a monolithicconstruction, or in an alternate embodiment, the support tube 140 caninclude multiple sections. The support tube 140 can have a uniformdiameter of any size, for example, to access a body cavity in accordancewith a laparoscopic procedure. The proximal end of the support tube 140can be coupled with the handle portion 123 of the stapling device 100.The support tube 140 may have a handle ring 144 that slidably engages anoutside surface of the support tube 140 and supports the alignment andconnection of the support tube 140 into the handle portion 123. A tubemount 174 may be affixed to the support tube 140 for attachment to thehandle portion 123.

The handle portion 123 of the stapling device 100 can be used tofacilitate insertion of the end effector 121 into the body cavity of apatient. The handle portion 123 can include mechanical or motorizedcomponents to facilitate actuation of the end effector 121. In oneembodiment, the handle portion 123 can include a right handle half 120and a left handle half 122 that can be coupled together in aclamshell-like fashion. The right handle half 120 and left handle half122 may be joined, for example, by handle nuts 168, 170 and handlescrews 160, 162, 164, or may be ultrasonically welded, press fit, glued,screwed together with self-tapping screws into holes molded into theright handle half 120, or otherwise assembled.

The handle portion 123 can include a trigger 146 that can be used toactuate and activate the stapling device 100. The trigger 146 caninclude a first mounting feature 148 and a second mounting feature 150that can be used to attach the trigger 146 such that it is pivotable ormoveable relative to the right handle half 120 and left handle half 122.A trigger stop 158 can be positioned in handle portion 123, adjacent thetrigger 146, and can include centering springs 152, 154 and a resetspring 156 that can be used, respectively, to center and reset thetrigger stop 158 in coordination with the use of the trigger 146. Oneembodiment of the operation of the handle portion 123 and the trigger146 is shown in more detail in FIGS. 5A-5B.

The tube mount 174 of the support tube 140 can engage features in theright handle half 120 and left handle half 122 to couple the supporttube 140 to the handle portion 123. The platform 142 can be coupledthrough the support tube 140 to a rack 176 of teeth or other engagementfeatures that can engage a pawl arm 128. The pawl arm 128 can be biasedtoward the rack 176 using a pawl spring 130. The pawl arm 128 can beretained at least partially within the handle portion 123 and caninclude a left release lever 126 and a right release lever 124 that canbe used ambidextrously to overcome the bias of the pawl spring 130 andlift a pawl 208 of the pawl arm 128 from the rack 176.

In one embodiment, an electric motor 192 containing an armature 193 canbe insertable into a motor mount 194 and can be attached via screws 190to be used as a driver or actuator. In certain embodiments, the electricmotor 192 can be selectively removable from the motor mount 194 forreuse by an operator, where the end effector 121 and/or support tube 140may be single use and disposable.

The electric motor 192 and a switch 196 can be held in the motor mount194 using a cap 197 and an outer cap 198. The armature 193 can becoupled to a rotating member 180 using a gear 186 and a hub 188. Athrust washer 184 can be used to provide an abutment for a triggerreturn spring 181. A switch 134 associated with a switch pad 132 can beused in coordination with the switch 196 to engage the electric motor192 to activate the rotating member 180. The motor mount 194 can bemountable into the handle portion 123 using a left mount arm 195 and aright mount arm 199 and can be fixed in place via pins formed in theleft handle half 122 and left release lever 126, using screws such ashandle screw 164, or other holding structures or methods.

FIG. 5A is a cross-sectional side view of the handle portion 123 of thestapling device 100 shown in a first open position (see, for example,FIG. 2A). FIG. 5B is a cross-sectional side view of the handle portion123 transitioned to a second closed position (see, for example, FIG.2B). The second mounting feature 150 of the trigger 146 can include anelongated slot such that a trigger pin 204 can move within the secondmounting feature 150 in a non-load bearing direction while the trigger146 applies a load to the platform 142 as the trigger 146 is pulledproximally. As the trigger 146 is urged proximally, the second mountingfeature 150 can correspondingly apply a force to the trigger pin 204that urges the platform 142 proximally. The rack 176 can be rigidlyattached to a proximal end of the platform 142 such that as the trigger146 is urged proximally the teeth 206 of the rack 176 engage the pawl208 on the pawl arm 128 to prevent distal movement of the rack 176 andplatform 142. The rack 176 and platform 142 can be prevented from movingdistally until, for example, a left release lever 126 (FIG. 3) or aright release lever 124 (FIG. 3) is pressed to release the pawl 208 fromthe teeth 206 of the rack 176. A plurality of teeth 206 on the rack 176can provide for incremental closing of the end effector 121 as thetrigger 146 is pulled, which can allow for precise positioning of theend effector 121 on tissue. The clinician can urge the trigger 146proximally until a desirable compression or position on the tissue isachieved. If the clinician needs to reposition the stapling device 100,the right release lever 124 or left release lever 126 can be actuated toopen the stapling device 100 to release the tissue.

The handle portion 123 can include a trigger stop 158 having a triggerstop tip 210. As shown in FIG. 5B, the trigger 146 can be urgedproximally until a trigger edge 212 on the trigger 146 touches thetrigger stop tip 210, which can prevent further proximal movement of thetrigger 146. In one embodiment, when the trigger 146 engages the triggerstop the stapling device 100 is in the fully closed position (see, forexample, FIG. 2B). In the fully closed positioned, the endocutter can beused to deploy staples and/or transect tissue.

Referring to FIG. 5C, once the stapling device 100 is in a closedposition it can be transitioned to a third pre-firing position. In oneembodiment, the stapling device 100 can be fired only after the triggerstop 158 is moved laterally relative to the trigger 146 such that thetrigger stop tip 210 is aligned with a trigger release recess 202. Oncethe trigger stop 158 is aligned with the trigger release recess 202 thetrigger 146 can be urged further proximally such that the trigger stoptip 210 enters the trigger release recess 202. The trigger stop 158 canbe urged laterally by a clinician, for example, by compressing thecentering spring 152 or centering spring 154, to permit the trigger stoptip 210 to move laterally relative to the trigger edge 212 until thetrigger stop tip 210 engages the trigger release recess 202.

Referring to FIG. 5D, when the trigger stop tip 210 is aligned with thetrigger release recess 202, the trigger 146 can be urged more proximallyto a fourth firing position to actuate a switch 172 that engages theelectric motor 192 to drive the blade assembly 108. Driving the bladeassembly 108 can correspondingly cause the stapling device 100 toprovide a staple line while simultaneously cutting tissue. A nut 109(FIGS. 6 and 7) can be coupled to the blade assembly 108 and cantransfer a force to the blade assembly 108 from the rotating member 180as the rotating member 180 is actuated by the electric motor 192.

Referring now to FIG. 5E, when the trigger 146 is released, the resetspring 156 can urge the trigger stop 158 distally such that the switch172 disengaged the electric motor 192 is turned off. The centeringspring 152 and centering spring 154 can then re-center the trigger stop158 and reset the stapling device 100 such that the electric motor 192cannot be inadvertently reengaged.

Referring to FIG. 6, shown is a perspective view of the blade assembly108 illustrating that the nut 109 can be attached to the blade assembly108 via a pin 145, a spot weld, or can be formed monolithically as aunitary construction with the blade assembly 108. The blade 107 can beaffixed to a distal end of the blade assembly 108 and can be urged, forexample, from a distal position to a proximal position to cut tissueduring staple formation. FIG. 7 illustrates a cross-sectional view ofone example of the relationship between the support tube 140, theplatform 142, the nut 109, and the rotating member 180. It will beappreciated that any suitable coupling that facilitates the transfer offorce from the rotating member 180 to the blade assembly 108 iscontemplated.

In embodiments, the blade 107 can be urged proximally to cut tissuewhile at the same time deploying the staples from the cartridge 110. Itmay be advantageous for the blade 107, supported by an elongate beam226, to be positioned at the distal end of the end effector 121 prior todelivering staples and cutting the tissue. The elongate beam 226 mayprovide additional support to the cartridge frame 116 during positioningand transition of the end effector 121 from the open position to theclosed position.

As discussed with reference to FIG. 3A, FIG. 3B, and FIG. 4, the blade107 can include a top portion 228 that can be sized to slidably movewithin the anvil blade channel 139 and the blade 107 can include abottom portion 230 that can be sized to slidably move within thecartridge blade channel 141. In one embodiment, as the blade 107 isurged proximally to cut tissue, the top portion 228 and the bottomportion 230 of the blade 107 can compress the end effector 121 toprovide advantageous compression to the tissue.

It will be appreciated that the manually operated embodiments of thestapling device 100 are described by way of example only. For example,the handle of the stapling device 100 can be a control unit from asurgical robot and the stapling device 100 can be actuated remotelyusing a surgical robot or other electromechanical systems, such as byelectric motor, cable and pulley, pneumatic or hydraulic mechanisms.

FIG. 8 is a cross-sectional side view of selected components of thehandle portion 123 of the stapling device 100 in accordance with atleast one embodiment. The rotating member 180 can include threaded orspiral cut grooves 214 that can be used to actuate the stapling device100. As the rotating member 180 is actuated, corresponding threads onthe nut 109 can urge the nut 109 in a proximal or distal direction. Thenut 109, being coupled to the elongate beam 226 of the blade assembly108, can advance the blade 107 in a proximal or distal direction.

FIG. 9 is a side view of one end of the end effector 121 in accordancewith at least one embodiment. In the illustrated version, the cartridgeframe 116 is illustrated extending into the support tube 140, which mayprovide advantageous stiffness and support for the end effector 121. Thecartridge frame 116 can include a ramp 216 that can be unitarily formedas a monolithic structure with the cartridge assembly 103, or may be aseparate component that can be affixed to the cartridge frame 116. Theramp 216 can be positioned to interfere with a ramp surface 220 of themaster link 106. As the platform 142 is advanced distally, the rampsurface 220 can engage the ramp 216 to urge the master link 106 upwardto open the end effector 121. The ramp 216 can have any suitable shapeand configuration that can cause the master link 106 to open orotherwise space apart the cartridge assembly 103 and the anvil assembly101. In an alternate embodiment (not shown), the ramp can be replacedwith a spring to bias the master link in an open, or up, position.

As the platform 142 is advanced, the first master link pin 104 canengage the distal end of the master link slot 105 to urge the anvilassembly 101 upward or away from the cartridge assembly 103. The masterlink slot 105 can be an elongated channel that can be sized such thatthe platform 142 and master link 106 can move proximally and distallyalong a longitudinal axis to allow the master link 106 to apply anopening and closing force to the anvil frame 102. The master link slot105 can be sized such that, after the end effector 121 is fully closedand the master link 106 is horizontal within the support tube 140, themaster link slot 105 can permit the trigger 146 to be advanced fartherproximally to engage the trigger edge 212 with the switch 172.

Still referring to FIG. 9, the master link 106 can include a secondsurface 221 that can contact a tube edge 223 of the support tube 140 asthe trigger 146 is actuated. To close the end effector 121, as theplatform 142 is urged proximally, the second surface 221 can be pushedby the tube edge 223 to move the anvil frame 102 towards the cartridgeassembly 103. The ramp surface 220 can facilitate opening the staplingdevice 100 and the second surface 221 can facilitate closing thestapling device 100 for improved action of the stapling device 100during use. In one embodiment, coupling the first end of the master link106 to the platform 142 and the second end of the master link 106 to theanvil frame 102 can facilitate actuation of the end effector 121 withoutrequiring actuation of the support tube 140.

As shown in FIG. 9, the master link 106 can be pivotally attached at afirst end by the first master link pin 104 at a second end of by thesecond master link pin 138. The master link 106 can have a linearconfiguration or, as shown in FIG. 9, the master link can have a firstlinear portion originating at about the second master link pin 138 and asecond linear portion connected to the anvil frame 102 via the firstmaster link pin 104. The first linear portion and the second linearportion can be offset, for example, between 1.5 and 10.0 millimeters,and may be offset by 2.5 millimeters. The included angle between thelinear portions and the ramp surface 220 and second surface 221 can be,for example, from 20 degrees to 50 degrees, or 37 degrees. The distancebetween the first master link pin 104 and the second master link pin 138can be from 10 mm to 50 mm, from 15 mm to 20 mm, or 18 mm. The length ofthe second surface 221 can be from 15 mm to 22 mm, from 10 mm to 30 mm,or 18 millimeters from the top of the first linear portion to the top ofthe second linear portion. The master link slot 105 can have a length of4 mm to 9 mm, 3 mm to 8 mm, or 6 mm to provide for desirable movement ofthe first master link pin 104 within the master link slot 105. Theheight and width of the master link 106 can be from 3 mm to 13 mm, or 6mm, for example, to provide for strength and rigidity while stillfitting within the profile of the end effector 121. The material of themaster link 106, in combination with the size of the master link 106,can be selected to ensure the master link 106 can withstand closureloads of, for example, from 10 lbs. to 100 lbs. In one embodiment, thewidth of the master link 106 is 8 mm, the height of the master link 106is 4.6 mm, and the material of construction for the master link 106 isstainless steel.

FIG. 10 depicts a bottom plan view of the anvil assembly 101 accordingto one embodiment. The blade 107 is shown positioned at one end of theanvil frame 102 in a first opening 234. As the anvil assembly 101 isclosed against the cartridge assembly 103, the cutting 107 can enter theanvil plate channel 137 to cut tissue between the staples. Afterreaching the end of its cutting sequence, the blade 107 can enter asecond opening 236 that can allow the end effector 121 to be opened. Theblade 107 can be guided through the anvil plate channel 137 to keep theblade 107 centered.

FIG. 11 is a perspective view of a stapling device 300 in accordancewith one embodiment. The stapling device 300 can include an endocutter308 and a motor assembly 315. The stapling device 300 comprising an endeffector 321 including an anvil assembly 301 and a cartridge assembly303, a support tube 340 and a handle portion 323. The anvil assembly 301can function as a first jaw of the end effector 321 and the cartridgeassembly can function as a second jaw of the end effector 321. The endeffector 321 can be connected to the handle portion 123 via a supporttube 340. The handle portion 323 can include a handle 311 and a trigger304 for actuating the stapling device 300.

The handle portion 323 can include a mode button 324 for switchingbetween operational modes. For example, in a first mode, the trigger 304can be pressed upwards to open the jaws (e.g., the anvil and cartridge)or pressed downward to close the jaws. When the jaws are in a closedposition, the mode button 324 can be depressed to transition thestapling device 300 into a firing mode. When in the firing mode,depressing the trigger 304 can fire the stapling device 300 tosimultaneously form a staple line comprising of one or a plurality ofrows of staples while cutting tissue. In one embodiment, depressing thetrigger 304 in the firing mode can deploy a staple line including sixrows of staples, where a knife (not shown) can simultaneously cut tissuebetween a third and a forth row of the staples.

FIG. 12 depicts an exploded perspective view of the endocutter 308 inaccordance with at least one embodiment. The anvil assembly 301 caninclude an anvil frame 302 and an anvil plate 312. The anvil plate 312can be welded to the anvil frame 302, or may be otherwise attached suchas by gluing, brazing, sintering, machining, 3D printing or the like. Acartridge 310 containing a plurality of staples can be attached to thecartridge frame 316 by a first cartridge pin 341 at a first end and asecond cartridge pin 318 at a second end, or alternately the cartridge310 can be attached to the cartridge frame 116 via snap fit, gluing, orother attachment methods.

In the embodiment illustrated in FIG. 12, the cartridge frame 316 can beinsertable at its proximal end into the support tube 340 to align andconnect the end effector 321 of the endocutter 308 to the handle portion323. A blade assembly 322 can include a knife or blade 307 that can becoupled to a rotating member 380 via a bushing.

The handle portion 323 can include a right handle half 320 and a lefthandle half 322 that can be held together in a clamshell-like fashion.The right handle half 320 and left handle half 322 can be joined by, forexample, ultrasonic welding, glue, screws, gripper pins or press-fitpins fit into holes molded into the handle, or other assembly methods. Aleft handle shell 350 and a right handle shell 352 can be used toprovide a pleasing aesthetic look to the exterior of the handle portion323 by covering the left handle half 322 and the right handle half 320.

A drive screw 354 can be used to drive a control arm 351 via a controlarm nut 353. The drive screw 354 can be connected to a second drive gearcoupler 345 that can engage the motor assembly 315. The rotating member380 can be coupled to the motor assembly 315 via a firing drive gear 366and a second firing drive gear 369, where the second firing drive gear369 can engage the first drive gear coupler 356 that can be coupled withthe motor assembly 315. In one embodiment, the second firing drive gear369 and the first drive gear coupler 356 can be a single component orfeature.

FIG. 13 is a perspective view of the motor assembly 315 in accordancewith one embodiment. A first electric motor 335 and a second electricmotor 337 can be provided in a motor housing 313. In one embodiment, thefirst motor gear 363 can be coupled with the first drive gear coupler356 (FIG. 12) and a second motor gear 365 can be coupled with the seconddrive gear coupler 345 (FIG. 12). The motor housing 313 can include aleft motor housing half 327 and a right motor housing half 316. Themotor housing 313 can include snaps 317 to couple the motor assembly 315with the handle portion 323. A strain relief 319 can be provided tosupport wiring to the motor assembly 315. A connector 325 can providefor electrically coupling the trigger 304 (FIG. 12) and other electricalcomponents between the motor assembly 315 and the stapling device 300.

FIG. 14A is a side view of the stapling device 300 in accordance withone embodiment showing the end effector 321 in an open position. The endeffector 321 can include a first jaw comprising the anvil assembly 301and a second jaw comprising the cartridge assembly 303. The end effector321 can include a master link 306 operably coupled with the motorassembly 315.

FIG. 14B is a side view of the stapling device 300 showing the endeffector 321 in a closed position. The end effector 321, in its closedposition, can be ready for firing, which can include deploying staplesand/or cutting tissue. In one embodiment, the end effector 321 caninclude a blade 307 (FIG. 12) to cut tissue while deploying staples.

FIG. 15 depicts a cross-sectional side view of the handle portion 323 ofthe stapling device 300 in the open position (e.g., the position shownin FIG. 14A). A second drive gear coupler 345 for opening and closingthe end effector 321 can be coupled to the second motor gear 365 (FIG.13) associated with the second electric motor 337. The second drive gearcoupler 345 can rotate the drive screw 354 to open and close the endeffector 321 to transition the end effector 321 between an open positionto a close position, and vice versa. In FIG. 15, the control arm nut 353is shown in its distal-most position on the drive screw 354 such thatthe master link 306 is fully extended and the end effector 321 is in theopen position. A control arm distal limit switch 368 can be contacted bythe control arm nut 353 in the illustrated position, when the endeffector 321 is in the fully open position, to interrupt power to thesecond electric motor 337. The first drive gear coupler 356 can becoupled to the second motor gear 365 to deploy staples from the staplingdevice 300 while simultaneously cutting tissue.

FIG. 16 depicts a side view of the end effector 321 of the staplingdevice 300 shown in the open position. The master link 306 can beattached to a first end of the anvil frame 302 by a first master linkpin 320 such that the first master link pin 320 can pivotally andslidably engage master link slot 305. The master link slot 305 can be achannel parallel to the longitudinal axis of the anvil assembly 301, orthe master link slot 305 can be angled up or down relative to thislongitudinal axis. A second master link pin 338 can be used to pivotallycouple the master link 306 to the control arm 351.

FIG. 17 depicts a cross-sectional side view of the handle portion 323 ofthe stapling device 300 shown in the closed position. The control armnut 353 is illustrated in its proximal-most position on the drive screw354 such that the anvil assembly 301 is closed relative to the cartridgeassembly 303. In one embodiment, when the end effector 321 is closing,the control arm nut 353 can travel proximally until it contacts aproximal limit switch 355. When the control arm nut 353 contacts theproximal limit switch 355 it can interrupt power to the second electricmotor 337. The stapling device 300 can be configured such that it cannottransition into a firing mode until the control arm nut 353 engages theproximal limit switch 355 to ensure that the stapling device 300 is inthe closed position before firing.

FIG. 18 depicts a side view of the end effector 321 of the staplingdevice 300 shown in the closed position. The master link 306 isillustrated as inserted partially into the support tube 340 such thatthe anvil assembly 301 and the cartridge assembly 303 are in a closedposition ready for firing.

FIG. 19 is a side view of a drive assembly 460 for simultaneouslystapling and cutting tissue. The drive assembly 460 can include a bladeassembly 408 including a blade 407 coupled to a beam 426. The beam 426can include a nut 409 that can threadedly engage a rotating member 480.The rotating member 480 can be operably coupled with the first electricmotor 412 such that rotation of the rotating member 480 urges the nut409 proximally. During operation, activating the first electric motor412 can urge the nut 409 proximally such that the beam 426 and bladeassembly 408 are correspondingly moved in a proximal direction. As theblade assembly 408 is urged proximally a cutting edge 432 on a blade 407can transection tissue. The blade 407 can include a top portion 428 anda lower portion 430 that can compress an anvil and a cartridge of an endeffector when urged proximally.

Still referring to FIG. 19, when the blade assembly 408 is pulled to itsproximal-most position the nut 409 can engage a firing complete limitswitch 468. When the nut 409 engages the firing complete limit switch468 power to first electric motor 412 can be interrupted. It iscontemplated that the nut 409 can be attached to the blade assembly 408or beam 426 in any suitable fashion such as via a pin, a spot weld orother attachment method. Alternatively, the nut 409 can be formedmonolithically as a unitary structure with the blade assembly 408 or thebeam 426.

FIG. 20 is a side view of a drive assembly 560 for opening and closingan anvil assembly 501 according to one embodiment. Anvil assembly 501can be moveably coupled with a master link 506, where the master link506 can be pivotally coupled with a distal end of a platform 542.

In the illustrated embodiment, the master link 506 includes a firstmaster link pin 504 that can engage a master link slot 505 positioned atthe proximal end of the anvil assembly 501. The first master link pin504 can translate within the master link slot 505 to facilitate openingand closing of the anvil assembly 501. A proximal end of the platform542 can include a drive nut 567 that can threadedly engage a drive screw554. The drive nut 567 and the drive screw 554 can be coupled such thatrotation of the drive screw 554 in a first direction urges the drive nut567 proximally and rotation of the drive screw 554 in a second directionurges the drive nut 567 distally. A proximal end of the drive screw 554can be coupled with a second motor gear 565 that is rotationally coupledwith a second electric motor 514. During operation, the second electricmotor 514 can rotate the drive screw 554 clockwise or counterclockwiseto open and close the anvil assembly 501, respectively.

Still referring to FIG. 20, the drive assembly 560 can include a distallimit switch 557 and a proximal limit switch 555. When the anvilassembly 501 is in the fully open position, the drive nut 567 can be inits distal-most position such that it contacts the distal limit switch557 to interrupt power to the second electric motor 514. When the anvilassembly 501 is in the fully closed position, the drive nut 567 can bein its proximal-most position such that it contacts the proximal limitswitch 555 to interrupt power to the second electric motor 514.

FIG. 21 is a side view of a drive assembly 660 for opening and closingan anvil assembly 601 according to an alternate embodiment. Anvilassembly 601 can be moveably coupled with a master link 606, where themaster link 606 can be pivotally coupled with a distal end of a platform642.

In the illustrated embodiment, the anvil assembly 601 can include adistal slot 669 that can engage a pin (not shown) positioned at thedistal end of the anvil assembly 601 to allow for movement of the pinwithin the distal slot 669 to facilitate opening and closing of thedrive assembly 660. The proximal end of the anvil assembly 601 caninclude a fixed pin 604 that can pivotally couple the anvil assembly 601and the master link 606. A proximal end of the platform 642 can includea drive nut 667 that can threadedly engage a drive screw 654. The drivenut 667 and the drive screw 654 can be coupled such that rotation of thedrive screw 654 in a first direction urges the drive nut 667 proximallyand rotation of the drive screw 654 in a second direction urges thedrive nut 667 distally. A proximal end of the drive screw 654 can becoupled with a second motor gear 665 that is rotationally coupled with afirst electric motor 614. During operation, the first electric motor 614can rotate the drive screw 654 clockwise or counterclockwise to open andclose the anvil assembly 601, respectively.

Still referring to FIG. 21, the drive assembly 660 can include a distallimit switch 657 and a proximal limit switch 655. When the anvilassembly 601 is in the fully open position, the drive nut 667 can be inits distal-most position such that it contacts the distal limit switch657 to interrupt power to the first electric motor 614. When the anvilassembly 601 is in the fully closed position, the drive nut 667 can bein its proximal-most position such that it contacts the proximal limitswitch 655 to interrupt power to the first electric motor 614.

During closure of an end effector, the anvil may interfere with thecartridge when closing on tissue because of the anvil's ability torotate or deflect slightly relative to the longitudinal axis from tissueloads. FIG. 22 is a perspective view of a distal portion of an anvilframe 701 according to one embodiment. The anvil frame 701 can include abevel feature, such as an anvil chamfer 771, that can guide the anvilframe into a channel 702 in a cartridge assembly 703 to help ensurealignment during closure. Tissue between the jaws may be thicker on oneside than the other of the end effector, where the anvil chamfer 771 mayassist with alignment if non-uniform tissue causes slight miss-alignmentbefore closing the jaws of the end effector. One or a plurality ofbevels can act as a lead-in feature that can work to align the endeffector to help ensure that staples are properly deployed in varyingtissue thicknesses.

FIG. 23 is a perspective view of a motor controller 870 according to oneembodiment. The motor controller 870 can include a controller housing872 having an on/off switch 874, a display 875 and a device cableconnector 876. The on/off switch 874 may provide for wall power, such as110 Volt or 220 Volt AC power from a wall outlet, or may provide forbattery power to the motor controller 870. The device cable connector876 may connect multiple wires from the motor assembly of a staplingdevice to the motor controller 870. For example, the device cableconnector 876 may provide positive and negative voltage wires to a firstelectric motor (e.g. first electric motor 335 shown in FIG. 13),positive and negative voltage wires to a second electric motor 337(e.g., second electric motor 337 shown in FIG. 13), wires to a trigger(e.g., trigger 304 shown in FIG. 12), positive and negative sense wiresto each of a firing complete limit switch 368 (FIG. 15), a proximallimit switch 555 (FIG. 20) and a distal limit switch 557 (FIG. 20), aswell as any other wires useful for an endocutter.

FIG. 24 is an exploded perspective view of the motor controller 870according to one embodiment. A lid 873, which can be part of thecontroller housing 872, can contain the components inside the controllerhousing 872. In the embodiment illustrated in FIG. 24, wall power can bebrought into the controller housing 872 via an electrical inlet 878. Afan 880 may also be included to cool the interior of the controllerhousing 872. A pair of speakers 882 can be provided to inform the userof the stapling device conditions, such as, for example, jaws open, jawsclosed, firing complete, ready to fire or other useful information. Thedisplay 875 can be used to provide visual directions, data, errorconditions, instrument identification, or other useful data.

A motor controller board 828 can provide electrical power to the firstelectric motor 335 (FIG. 13) or the second electric motor 337 (FIG. 13)when appropriate. The motor controller board 828 can be directed by aprocessor board 830 to turn on or off the first electric motor 335 orthe second electric motor 337. The processor board 830 can contain aprocessor, such as an ARM processor or other processor, useful incontrolling a stapling device. For example, the processor board 830 cancontain software that reads the condition of the limit switches 555,557, 368 (FIGS. 15 and 20) and the trigger 304 (FIG. 12) and can controlthe motor controller board 828 to, for example, open and close the jaws,fire the system, or perform other useful functions.

In one example embodiment, the ARM processor can be used to communicatewith an endocutter (for example, stapling device 100 shown in FIGS. 2Aand 2B). For example, the stapling device 100 may include an EEPROM orother memory retaining device that can be encoded with a serial numberduring manufacturing. The memory can be used to provide information tothe motor controller. For example, the processor can be capable ofmeasuring and recording opening and closing motor amperage duringactivation on the manufacturing line; firing motor amperage duringactivation on the manufacturing line; opening and closing motor amperagein clinical use; firing motor amperage during activation in clinicaluse, or other data useful to the manufacturer or operator. This data canalso be relayed to the motor controller 870 and stored. Such informationcan also be displayed during firing to the user by way of a connectionof the motor controller 870 to a screen or display that can beincorporated into the stapling device 100, in the motor controller 870,or the data may be transmittable to a monitor used by a laparoscopiccamera in a minimally invasive procedure.

FIG. 25 depicts a sectioned perspective view of a portion of the endeffector 321 of the stapling device 300 shown in FIG. 11. A plurality ofstaple drivers 332 can be positioned in a cartridge 310 beneath aplurality of staples 334 in a plurality of staple pockets 336. The anvilframe 302 can include an anvil channel 344 that can accept a top portion328 of blade 307. A staple driver ramp 343 can slide or otherwise movepast a plurality of driver ramp slots 342. As the stapling device 300 isfired, the staple driver ramp 343 can engage the staple drivers 332 todrive the staples 334 into the anvil assembly 301. Behind each stapleformed, the cutting edge 339 of the blade 307 can transect the tissueretained between the anvil assembly 301 and the cartridge assembly 303.Staple driver 332 heights can range from 1.5 mm to 4.5 mm, for example,and staple 334 lengths can range from 3.0 mm to 5.0 mm, for example. Incertain embodiments, relatively tall drivers and short staples can beused for thin tissue and relatively short drivers can be used with longstaples for thick tissue.

FIG. 26A is a cross-sectional side view of an end effector 321 of astapling device 300 according to one embodiment. In the illustratedembodiment, an anvil plate 312 is flat and a cartridge 310 includesthree staple driver 332 heights in sections 390, 391, and 392, that aresized to drive equal length staples 334. Providing section 390 (e.g.,2.2 mm driver height to form a 1.2 mm formed staple), section 391 (e.g.,2.7 mm driver height to form a 1.7 mm formed staple), and section 392(e.g., 3.2 mm driver height to form a 2.2 mm formed staple) can allowfor variable tissue thickness within the stapling device 300 during use.A taller driver height can create a staple through a thinner tissuethickness while a shorter driver height can provide a staple appropriatefor thicker tissue. The cartridge 310 clamping surface can be angledrelative to the anvil, such as from 0.1 degrees to 0.35 degrees, or 0.25degrees, to provide uniform compression on the stomach, which hasnon-uniform tissue thickness.

FIG. 26B is a cross-sectional side view of the end effector 321 assemblyof the stapling device 300 according to an alternate embodiment. In theillustrated version, the anvil plate 312 is flat and the cartridge 310can include three staple driver 332 heights in sections 390, 391, and392 that can drive three or more different length staples 334.

FIG. 26C is a cross-sectional side view of the end effector 321 of thestapling device 300 according to an alternate embodiment. In theillustrated version, the anvil plate 312 can be angled and the cartridge310 can include identical staple driver 332 heights. In one embodiment,the cartridge 310 can include two different staple 334 lengths, wherelonger leg length staples (e.g., 4.4 mm) can be provided in a proximalportion of the cartridge 310 and shorter leg length staples (e.g., 3.8mm) can be provided in a distal portion of the cartridge 310. In anotherembodiment, equal length staples can used along the entire length of thecartridge 310. In other embodiments, different staple lengths can beused in different rows or within a row at different locations along thelength of the stapling device 300 to accommodate tissue thickness. Rowto row variations can account for variation in tissue thickness on apatient-to-patient basis. Changing staple height within a row canaccount for the change in tissue thickness that can occur from one endof the stomach to the other. Providing an anvil plate 312 that is angledmay be advantageous when stapling different thickness tissue to provideuniform tissue compression from the distal-most portion to theproximal-most portion of the cartridge 310 as the stapling device 300 isfired.

FIG. 26D is a cross-sectional side view of the end effector 321 of thestapling device 300 according to an alternate embodiment. In theillustrated embodiment, the anvil plate 312 is angled and the cartridge310 includes a single staple driver 332 height to drive variable lengthstaples 334. Any suitable number of different staple heights can becombined with the anvil plate 312 having a slope to provide desirabletissue compression and a staple line with high integrity. For example,as illustrated in FIG. 26D, the cartridge can include three differentstaple heights positioned along thirds of the cartridge 310.

FIG. 26E is a cross-sectional side view of the end effector 321 of thestapling device 300 according to an alternate embodiment. In theillustrated version, the anvil plate 312 is angled and the cartridge 310can include staples having a uniform length. Any suitable combination ofanvil plate angle, driver height, and staple heights is contemplated.

FIG. 27 depicts a Method 250 of operating the end-effector portion of anendocutter (for example, stapling device 300) according to oneembodiment. Method 251 may provide for safe and effective activation anduse of the stapling device. Steps illustrated in FIG. 27 may beimplemented in software on the processor board 830 (FIG. 24), infirmware, using a programmable gate array, or by other suitable methodsfor implementing logic control. The Method 251 includes an On/Off Mode205, a Closure System Mode 207, a Firing System Mode 209, an Idle SystemMode 211 and a Manufacturing Knife Reset Mode 213.

The On/Off Mode 205 can include delivering or eliminating power to thestapling device 100. The Closure System Mode 207 can provide for openingand closing of the end effector, jaws, or anvil and/or anvil andcartridge of a stapling device to provide for placement and adjustmentof the endocutter on tissue. The Firing System Mode 209 can includesafety and detection steps to provide for complete and effective firingof the staples. The Idle System Mode 211 can communicate function andoptions to the user, as well as waiting for user direction. For example,the Idle System Mode 211 can include use of a programmable memory, suchas an EEPROM provided in the connector or handle that communicatesinformation about the instrument to the controller. The ManufacturingKnife Reset Mode 213 may be useful during the testing and manufacturingof an endocutter to verify functionality during manufacturing and toposition components properly for use.

The Firing System Mode 209 can include feedback to the operatorregarding exceeding limits, such as compression limits, motor drivelimits, tissue thickness limits or other limits useful to the operator.For example, motor current may be monitored by the controller, and whena predetermined motor current level is reached, the controller mayprovide feedback to the operator that the motor is reaching its loadlimit such that the operator can make a decision to alter the procedureor perform some other action.

In one embodiment, an endocutter or stapling device system in accordancewith embodiments described herein may have a unique serial number orother identifier to allow the operator to record the particular serialnumber of the instrument used in a patient's record. When an instrumentis plugged into the controller, such as motor controller 870, thecontroller may communicate with the memory and provide the serial numberon a display of the controller. The memory may also be used to recordinformation regarding the use of the instrument. For example, an eventlog may be recorded into the memory from the controller that recordsmotor load, number of openings or closings of the instrument, number offirings of the instrument, error codes or other useful information ontothe memory for later review.

FIG. 28 is a flow chart illustrating a Method 251 according to oneembodiment. Method 251 can include a System Ready State 252 leading to aClosure Switch Active/All Other Switches Inactive Decision 253. Switchesmay include, for example, mode button 324, proximal limit switch 555,distal limit switch 557, or other useful switches. If the closure switchis active and any other switch is also active, then the system can enteran Error State 254. If no switches other than the closure open switchare active, then the system can enter a Closure System Mode 255. Fromthe Closure System Mode 255, the Method 251 can then perform a TriggerRead 256, and determines whether the trigger is in a trigger up ortrigger down state. If the Trigger Read 256 returns a trigger upcondition, a Closure-Open Switch Activated Decision 257 can occur. Ifthe Closure-Open Switch Activated Decision 257 is NO, a Motor OpensDevice Condition 259 can occur and then another Trigger Read 256 canoccur. If the Closure-Open Switch Activated Decision 257 is YES, then aDevice Open Condition 258 can occur.

If, during a Trigger Read 256, a trigger down condition is detected,then a Closure Closed Switch Activated Decision 261 can be made. If theClosure Closed Switch Activated Decision 261 is NO, then a Motor ClosesDevice 260 condition can occur, and another Trigger Read 256 can follow.If the Closure Closed Switch Activated Decision 261 is YES, then aDevice Closed Condition 262 can occur. Many conditions, such as, forexample, the Device Closed Condition 262, can provide feedback to theoperator regarding the device, such as by blinking an LED light,providing an audible sound, or other feedback type. For example, audiofiles may be created and provided at times during the Method 251 toprovide information to the user regarding system states, conditions,errors, or functionality of the stapling device 100. The Method 251 inFIG. 25 can continue at Link 263 to FIG. 29.

FIG. 29 is a flow chart illustrating the Method 251, starting at theLink 263 that links the portion of the Method 251 from FIG. 28 to theportion of the Method 251 illustrated in FIG. 29. When the Method 251 isin the Device Closed Condition 262, the Method 251 can utilize a SafetySwitch 264 to make sure that the operator intends to fire the endocutterbefore a Firing System Mode 265 is enabled. A suitable Safety Switch 264may be, for example, mode button 324 shown in FIG. 11. If the FiringSystem Mode 265 is enabled, then a Firing Started Decision 266 can bemade. If the Firing Started Decision 266 is NO, then both a SafetySwitch 268 active condition and a Trigger Up 267 condition are both metbefore a Closure System Mode 271 can be entered. If the Firing StartedDecision 266 is YES, then a Trigger Down Condition 269 can precede aFiring Limit Switch Activated Decision 283. If the Firing StartedDecision 266 is YES, then a Trigger Down Double-Click 270 can precede anActivate Firing Motor Condition 272. During the Activate Firing MotorCondition 272, the endocutter can fire and resect tissue until a FiringLimit Switch Activated Decision 283 determines that the firing limitswitch is active.

If the Firing Limit Switch Activated Decision 283 is YES, then a FiringMotor Stops Condition 274 can be entered, the firing motor stops, andthe Method 251 can enter a Firing Completion Mode 279 and then enter anIdle System Mode 280. If the Firing Limit Switch Activated Decision 283is NO then Firing Motor Continues Condition 273 can occur until thefiring limit switch activates, such as, for example, proximal limitswitch 555. The Idle System Mode 280 is further described below withreference to FIG. 30.

FIG. 30 is a flow chart illustrating the Method 251, beginning at theIdle System Mode 280. The system can idle until a Trigger Up Condition281 or a Trigger Down Condition 282 occurs. A Trigger Up Condition 281can prompt a Closure-Open Switch Activated Decision 284. If theClosure-Open Switch Activated Decision 284 is YES, the closure motor isstopped and a Device Open Condition 289 can occur. If the Closure-OpenSwitch Activated Decision 284 is NO, then the motor can continue to openthe endocutter until the trigger is released or the closure open switchis activated. A Trigger Down Condition 282 can prompt a Closure-ClosedSwitch Activated Decision 286. If the Closure-Closed Switch ActivatedDecision 286 is YES, the losure motor can be stopped and a Device ClosedCondition 290 can occur. If the Closure-Closed Switch Activated Decision286 is NO, then the motor can continue to close the endocutter until thetrigger is released or the closure closed switch is activated.

FIG. 31 is a perspective view of a stapling device 900 in accordancewith one embodiment. The stapling device 900 can include an endocutter908 and a motor assembly 915. The endocutter 908 can include an endeffector 921 including an anvil assembly 901 and a cartridge assembly903, or a first jaw and a second jaw respectively, for the clamping,stapling, and/or resection of tissue. The end effector 321 can beconnected to a handle portion 923 via a support tube 940. The handleportion 923 can include a handle 905 including a trigger 904 foractuating the stapling device 900. The handle portion 923 can include amode button 924 for switching between operational modes. For example, ina first mode, the trigger 904 can be pressed upwards to open the jaws orpressed downwards to close the jaws. After the jaws are closed, the modebutton 924 can be depressed, changing the trigger 904 function from andopen/closed mode to a firing mode. When in firing mode, depressing thetrigger 904 can fire the stapling device 900 to simultaneously form astaple line while cutting tissue between the staple line.

As illustrated in FIG. 31, the stapling device 900 can include abuttress assembly comprising, in part, a plurality of cord supports 988positioned on the cartridge assembly 903 and the anvil assembly 901 toprovide for the attachment of a buttress material 991 (FIG. 32) to thestapling device 900. The cord supports 988 may be useful for attachingthe buttress material 991 before or during surgery. The buttressmaterial 991 can be used to add support and purchase to the staple lineto provide improved sealing to the cut tissue as the staples are formed.The buttress material 991 may be formed from absorbable ornon-absorbable material for either temporary or permanent applications.The cord supports 988 can be used to hold the buttress material 991 onthe stapling device 900 until after the staple line is formed, at whichpoint a cord 387 (FIG. 32) can be released to allow the buttressmaterial 991 to separate from the cord supports 988 and the staplingdevice 900. The cord supports 988 can be built into the anvil assembly901 or cartridge assembly 903 such that the buttress material 991 can beattached to the stapling device 900 prior to or during a procedure by,for example, threading a suture material or cord 987 through loops 999in the buttress material 991 and over or around the cord supports 988.

FIG. 32 depicts an exploded perspective view of the stapling device 900in accordance with one embodiment. The anvil assembly 901 can include ananvil frame 902 and an anvil plate 912. The cartridge assembly 903 caninclude a cartridge frame 916 and a cartridge 910. The cartridge 910 maybe attached to the cartridge frame 916 by a first cartridge pin 936 at afirst end and a second cartridge pin 918 at a second end, or alternatelythe cartridge 910 may be attached to the cartridge frame 916 via snapfit, gluing, or other attachment methods.

In the embodiment illustrated in FIG. 32, the cartridge frame 916 can beinsertable at its proximal end into a support tube 940 to align andconnect the end effector 921 of the stapling device 900 to a handleportion 923 of the stapling device 900. A blade assembly 922 can includea blade 907 coupled to a rotating member 980 via a nut 909.

The handle portion 923 can include a right handle half 920 and a lefthandle half 922 that can be held together in a clamshell-like fashion.The right handle half 920 and left handle half 922 can be joined by, forexample, ultrasonic welding, glued, screwed together with self-tappingscrews, gripper pins or press-fit pins into holes molded into the handleor other assembly method. A left handle shell 950 and a right handleshell 952 can be used to provide a pleasing aesthetic look to theexterior of the handle portion 923 by covering the left handle half 922and the right handle half 920.

A drive screw 954 can be used to drive a control arm 951 via a controlarm nut 953. The drive screw 954 can be connected to a drive gearcoupler 955 that can engage the motor assembly 915 (FIG. 31). Therotating member 980 is illustrated as coupled to a drive gear coupler956 via a first firing drive gear 966 and a second firing drive gear969. The drive gear coupler 956 can be coupled with the motor assembly915.

As illustrated in FIG. 32, the cord supports 988 can be attached to thecartridge 910, or to the cartridge frame 916 as illustrated in FIG. 31.The cord supports 388 can include lateral projections, hoops, tabs,hooks, loops, or other suitable structure to retain the buttressmaterial 991. The buttress material 991 can have the cord 987 integratedinto the buttress material 991 to provide support and to hold thebuttress material 991 onto the cartridge 910. For example, the cordsupports may be tubular shaped, having a “C” shaped cross-section (notshown), such that the cord supports are not completely closed. The open“C” shape can allow for the attachment of the buttress material to theend effector by pulling the cord over the tubular shape and allowing thecord to slip into the opening of the “C” to hold the buttress materialin place. Cord supports 988 can be provided on the anvil frame 902 or onthe anvil plate 112. The cord 987 can be, for example, suture material,wire cable, wire strand, individual wire, rope, monofilament, thread orother suitable material.

FIG. 33A is a side view of the stapling device 900 in accordance withone embodiment having an open end effector 921. The end effector 921 caninclude the anvil assembly 901, the cartridge assembly 903, and themaster link 906. The end effector 921 is illustrated before installationof the buttress material 991. It will be appreciated that the buttressmaterial 991 can be provided already attached to the end effector 921from the supplier, or the buttress material 991 can be placed on the endeffector 921, in the open position, during the surgical procedure. Forexample, the buttress material 991 can be provided in a sterile packageand can be opened in the sterile field during the surgical procedure.The clinician can then apply the buttress material 991 to the anvil orcartridge with the stapling device 900 in the fully open position andthread or loop the cord 987 on or through the cord supports 988 to holdthe buttress material 991 in place. Once the buttress material 991 hasbeen attached to the end effector 921, as shown in FIG. 33A, thestapling device 900 can be closed such that the end effector 921 can fitthrough a trocar into the operative site.

FIGS. 34A and 34B illustrate the buttress material 991 shown with thecord 987 engaged with the plurality of loops 999. The apertures 984defined by the buttress material 991 can be spaced between the loops 999and can be sized and positioned to correspond with the cord supports 988on the end effector 921. It will be appreciated that the buttressmaterial 991 can have any suitable size and shape to engage with andselectively retain the cord 987 or any other suitable buttress materialretention mechanism or structure. The cord 987 can be a single suturethreaded through the loops 999, or the use of multiple cords or suturesto secure the buttress material is also contemplated.

FIG. 35A illustrates the anvil assembly 901 shown with a plurality ofcord supports 988 prior to attachment of the buttress material 991. FIG.35B illustrates the anvil assembly 901 with the buttress material 991attached to the cord supports 988 with the cord 987 according to oneembodiment. FIG. 36 illustrates a perspective view of the staplingdevice 900 with the buttress material 991 attached to the anvil assembly901 and the cartridge assembly 903 with the cord 987.

As illustrated in FIG. 37, the stapling device 1000 can include abuttress 1088 having an adhesive that can be positioned on the cartridgeassembly 1003 and the anvil assembly 1001. The buttress 1088 can includea buttress material 1091 and one or a plurality of adhesive portions1090 that can be used to couple the buttress material 1091 to the anvilassembly 1001 or cartridge assembly 1003. The buttress 1088 can be usedto add support and purchase to the staple line to provide improvedsealing to the transected tissue as the staples are formed. The buttressmaterial 1091 can be formed from absorbable or non-absorbable materialfor either temporary or permanent applications. The adhesive portions1090 can be used to hold the buttress material 1091 on the staplingdevice 1000 until after the staple line is formed, at which point thestaple line can retain all or a portion of the buttress material 1091 onthe tissue.

In one embodiment, as shown in FIGS. 38A-38E, the buttress material 1091can be two-ply such that it includes an anvil buttress portion 1070 anda cartridge buttress portion 1072. As shown in FIG. 38A, the buttress1088 can include a pair of removable portions 1076 that can couple theanvil buttress portion 1070 to the cartridge buttress portion 1072 priorto use. The removable portions 1076 can be adhesively attached to thebuttress 1088, or can be attached with frangible portions or the like.

In one embodiment, the removable portions 1076 are pliable such that bypushing laterally inward on each of the removable portions 1076 theadhesive portions 1090 can pivot radially inward to contact the sides ofthe end effector 1021 (see, for example, FIGS. 38B-38C). In one methodof use, the buttress 1088 can be positioned in the end effector 1021, abacking material 1074 can be removed to expose the adhesive portions1090, the removable portions 1076 can be urged inward such that theadhesive portions 1090 are adhesively coupled with the end effector1021, and the removable portions 1076 can then be removed such that theanvil buttress portion 1070 is separated from the cartridge buttressportion 1072.

In an alternate embodiment, after the buttress 1088 has been placed inthe end effector in the closed position, the removable portions 1076 canbe removed to allow adhesive portions 1090 to flex such that eachadhesive portion 1090 can engage a side of the end effector 1021 forattachment.

Referring to FIGS. 38A-38C, the buttress material 1091 can include fouradhesive portions 1090 that can flank the buttress material 1091. Withreference to FIG. 38D, the anvil buttress portion 1070 and the cartridgebuttress portion 1072 can be sized such that each covers all or aportion of an anvil face 1012 and a cartridge face 1014, respectively,of the end effector 1021. The adhesive portions 1090 can be sized suchthat each can be folded to adhere to the sides of the anvil assembly1001 or the cartridge assembly 1003 as shown in FIG. 38D. Prior to use,each of the adhesive portions 1090 can include the backing material1074. For ease of removal, the backing material 1074 can be coupled withone or more removal threads 1093 (FIG. 38B) that, when pulled, canremove the backing material 1074 from the adhesive portions 1090. Asshown in FIG. 38E, when the stomach is resected, a portion of the stapleline can form a sleeve gastrectomy in cooperation with the buttressmaterial.

Varying pocket depth may improve the ability to achieve a minimumacceptable level of compression without over-compressing tissue. Varyingpocket depth may also mitigate the risk associated with the malformationof staples which can occur when there is a tissue thickness and stapleheight mismatch.

FIG. 39A is a bottom view of an anvil assembly 1101 in accordance withone embodiment. In FIG. 39A, an anvil plate 1112 is illustrated with sixrows of anvil pockets including first pocket row 1115, second pocket row1117, third pocket row 1119, fourth pocket row 1159, fifth pocket row1161, and sixth pocket row 1163. The staple pockets 1134 in the anvilplate 1112 can be shaped to receive and shape the tips of staples as thestaples are driven into the anvil plate 1112. When the staples engagewith the anvil plate 1112, the tips of each staple can be directed untileach has a substantially B-shaped configuration (see, for example, FIGS.42A-42C). The staple pockets 1134 can be machined into the anvil plate1112, eroded into the anvil plate 1112 using an EDM process, createdusing a precise electrochemical machining (PEM) process, formed using asintering process, molded using a metal injection molding process, orotherwise manufactured.

The anvil plate 1112 can be divided into a left anvil half 1111 and aright anvil half 1113 separated by a knife channel 1138. It will beappreciated that any suitable number of pocket rows having any suitablesize, shape, and orientation are contemplated. In the illustratedexample of FIG. 39A, the first pocket row 1115 and the second pocket row1117 are spaced more closely together than the third pocket row 1119.Similarly, the fourth pocket row 1159 and the fifth pocket row 1161 arespaced more closely together than the sixth pocket row 1163. It isunderstood that any spacing may be used between the rows, and that thespacing on the left anvil half 1111 may differ from the spacing on theright anvil half 1113. In the illustrated example, the pocket rows areshown having a staggered relationship, which may be beneficial inmaintaining the integrity of the staple line. It is understood that anydesirable stagger or spacing may be used with any suitable number ofstaple rows. In the illustrated embodiment, each of the staple rows isparallel to a longitudinal axis of the anvil assembly 1101, and extendsfrom a proximal end to distal end of the anvil assembly 1101, but one ormore rows may be offset and have any suitable length.

Spacing between rows of staples can be, for example, from 0.030 inchesto 0.060 inches, or 0.044 inches. Staple rows can be staggered relativeto each other in an overlapping fashion such that the middle of thestaple in one row is between two staples in an adjacent row. Anon-symmetrical stagger (not shown) of the staple rows on the left anvilhalf 1111 and the right anvil half 1113 may be useful in someprocedures, such as in a sleeve gastrectomy procedure, where tissue isremoved along one side of a cut and a gastric sleeve is formed on theother side of the cut. The integrity of the portion of the staple linealong the newly formed sleeve may be more critical and, as such, mayinclude additional staple rows, a different orientation of staples, orbe otherwise configured. In one embodiment (not shown), one half of ananvil has three staple rows and the other half includes two staple rows.

FIG. 39B is a cross-sectional view of the anvil assembly 1101illustrated in FIG. 39A at section G-G. As illustrated, each of thepocket rows, in addition to having variable sizing and position relativeto other pocket rows, can include variable pocket depths that can resultin different staple formation. For example, a first pocket 1125 fromfourth pocket row 1159 can have a first depth 1165. A second pocket 1127from fifth pocket row 1161 can have a second pocket depth 1166. A thirdpocket 1129 from sixth pocket row 1163 can have a third pocket depth167. In the illustrated embodiment, the first pocket 1125 depth isshallower than the second pocket 1127 depth, and the second pocket 1127depth is shallower than the third pocket 1129 depth. Varying the pocketdepth by row may be advantageous because it can allow tissue fartherfrom the knife channel 1138 to expand more than tissue closer to theknife channel 1138 when the procedure is complete. It should beunderstood, however, that any depth of the pockets and relationshipbetween the rows of pockets is contemplated.

FIG. 39C is a cross-sectional view of the anvil assembly 1101illustrated in FIG. 35 at section H-H in accordance with one embodiment.As illustrated, the depths of the pockets associated with each row canalso vary along the length of the anvil assembly 1101. As illustrated, afourth pocket 1131 from fourth pocket row 1159 has a fourth pocket depth1177, a fifth pocket 1133 from fifth pocket row 1161 has a fifth pocketdepth 1178, and a sixth pocket 1135 from sixth pocket row 1163 has asixth pocket depth 1179. In the illustrated embodiment, the fourthpocket 1131 depth is shallower than the fifth pocket 1133 depth, and thefifth pocket 1133 depth is shallower than the sixth pocket 1135 depth.Also, as illustrated the fourth pocket 1131 is shallower than the firstpocket 1125, the fifth pocket 1133 is shallower than the second pocket1127, and the sixth pocket 1135 is shallower than the third pocket 1129.A single staple row can include any desirable pocket depth to formstaples of any suitable shape or size. Pocket size can vary from largerat the proximal end of the anvil assembly 1101 to smaller at the distalend of the anvil assembly 1101, or vice versa. It will be appreciatedthat differently sized staples can be used in accordance with variouspocket depths and pocket rows to create a desirable tissue effect.

It may be advantageous to provide a stapling device with an anvilassembly 1101 that can accommodate a broad cross-section of the humanpopulation. In one example embodiment, the depth of the second pocketrow 1117 and the fifth pocket row 1161 can have a depth that correspondsto the median thickness of the stomach for the derived human population.The first pocket row 1115 and the fourth pocket row 1159 can have ashallower depth that can correspond to the 25th percentile of stomachthickness for the human population. The third pocket row 1119 and thesixth pocket row 1163 can have a depth that can correspond to the 75thpercentile of stomach thickness for the human population. Varying pocketdepth in this way to provide varying staple height in the rows mayeliminate cartridge selection issues such that a universally applicablecartridge can be provided. Varying pocket depth along the length orwidth of the staple line may account for variations in the humanpopulation. It will be appreciated that such embodiments can be combinedwith any suitable cartridge having any suitable size and shape ofstaples and any suitable shape and size of staple drivers.

FIG. 40 depicts a side cross-sectional view the end effector 1121 shownin an open position. In FIG. 40, a row 1180 of staple pockets 1134 isillustrated in sectioned view extending from a most proximal staplepocket 1182 to a most distal staple pocket 1183. The depths of thestaple pockets 1134 can vary continuously in depth from the mostproximal staple pocket 1182, the deepest pocket, to the most distalstaple pocket 1183, the shallowest pocket. As disclosed previously, thedepths may vary continuously along the length of the staple row or varydiscretely at one or more points along the length of the anvil assembly1101. It is contemplated that depths of the staple pockets 1134 may varyonly along the length of the anvil assembly 1101, only axially acrossthe width of the anvil assembly 1101, or both along the length and thewidth of anvil assembly 1101. It is further contemplated that the pocketdepth variation along a row closer to the knife channel 1138 can vary ata different scale or rate than another row positioned farther from theknife channel 1138.

FIG. 41 is an axial cross-sectional view of an anvil assembly 1201having an anvil plate 1212 in accordance with one embodiment. The anvilplate 1212 can include a plurality of anvil pockets 1234 having anysuitable shape. For example, the anvil plate 1212 can define afrustoconical cavity for each of the anvil pockets 1234, as illustrated,or the anvil pockets can have any shape such as curved, bowl-shaped, orthe like. FIGS. 42A-42C illustrate embodiments of formed staples 1332that can be formed by an anvil plate 1312 having pockets 1334 withdifferent depths.

With reference to FIGS. 43A-46, a stapling device can be configured toprovide asymmetrical staples to achieve a desired tissue effect.Referring to FIGS. 43A and 43B, an anvil plate 1412 can include a firstpocket 1466 having a first shape and a second pocket 1488 having asecond shape. As illustrated in FIG. 43C, the first pocket can include afirst cavity 1423 to receive the first tip 1426 of a staple 1332 (see,for example, FIG. 44) and a second cavity 1424 to accept a second tip1427 of the staple, where the first cavity 1423 has a different geometrythan the second cavity 1424. The first cavity 1423 can have a firstdepth 1478 and the second cavity 1424 can have a second depth 1481,where the first depth 1478 can be shallower than the second depth 1481.As illustrated in FIG. 44, the formed staple 1432 can be asymmetrical,which may be advantageous for providing uniform compression ormaintaining the integrity of a staple line. Pockets having any suitablecavities with any suitable geometry, angels, or sizing are contemplated.

Referring to FIGS. 45 and 46, altering the geometry of the pockets canproduce staples that are two-dimensional, along a single plane, orthree-dimensional, where the formed staple legs lie in different planes.For example, along the length of the anvil, the pocket shapes mayproduce varying amounts of offset in the staple legs makingthree-dimensional staples of varying offset in the axial direction. Inanother example, the pocket shapes may produce varying amounts of offsetin one row versus another row of a multi-row endocutter. Athree-dimensional staple provided along the cut tissue edge may providebetter hemostasis with a larger compressive zone.

FIG. 45 is a top view of a formed staple 1532 produced by an endocutterin accordance with one embodiment. The formed staple 1532 is illustratedas a three-dimensional formed staple with a first formed staple leg 1537offset from a staple base 1541 at an angle 1531, while a second formedstaple leg 1539 is offset in the other direction from the staple base1541 at an angle 1533. These opposed angle offsets can create athree-dimensional staple having tissue compression characteristics thatmay be beneficial. FIG. 46 is a perspective view of the formed staple1632 produced by an endocutter in accordance with one embodiment havinga three-dimensional shape.

FIG. 47 is a perspective view of a surgical stapling instrument 1725 inaccordance with one embodiment having a circular anvil assembly 1760.The surgical stapling instrument 1725 is illustrated as another type ofstapling instrument that may advantageously utilize the embodimentsdescribed herein. Other instruments that may advantageously utilize theembodiments described herein include linear staplers, linear cutters,endocutters or other surgical stapling and cutting instruments.

The anvil assembly 1760 can include a first circular anvil pocket row,and a second circular anvil pocket row. In a circular stapler, typicallythere are concentric circles of staple lines. It may be advantageous toprovide the inner-most circular row having a shallower or deeper staplepocket depth than the pocket depths on circular staple rows outside theinner-most circular row. It may also be useful to provide varying pocketdepths within a row as a function of position in the row. It may furtherbe useful to provide staples manufactured from different materials in aninner-row versus an outer row when there are two or more rows of staplesin the circular configuration.

The surgical stapling instrument 1725 can include a handle 1730 for thesurgeon to grasp, a shaft 1735 extending distally from the handle 1730,and a distal stapling end effector 1737 for the end-to-end anastomosisof cylindrical tissue. A firing trigger 1732 can be pivotably connectedto the handle 1730. Firing trigger 1732 is shown in the open positionextending from the handle 1730 and can be moveable to a closed positionadjacent to the handle 1730. The shaft 1735 can be slightly curved foranatomical placement of the stapling end effector 1737 into hard toreach lower anatomical positions. The stapling end effector 1737 canhave a fixed stapling head assembly 1740 and the anvil assembly 1760 canbe moveably connected to an anvil closure knob 1731. Rotation of theanvil closure knob 1731 can move the anvil assembly 1760 from the spacedaway position to a position adjacent to the stapling head assembly.

The anvil assembly 1760 can be detachably connected to the stapling headassembly 1740 and can be easily removed from the surgical staplinginstrument 1725 in the full open position. A firing trigger 1732 can bemoveable from an open position to a closed position to staple and cuttwo sections of colon or bowel together within the stapling end effector1737. A safety latch 1733 is shown in the locked position to lock thefiring trigger 1732 in the open position to prevent accidental firing.

Although examples have been illustrated referencing an endocutter in thefigures above, it is contemplated that the concepts presented herein mayalso be useful on other staplers, including, but not limited to, linearcutters, linear staplers, circular staplers, endocutters or otherinstruments incorporating staples.

It is further contemplated to have different pocket shapes in thedifferent rows laterally, longitudinally in different segments or bothlaterally and longitudinally. For example, a stronger staple thatresists deformation may be provided in the lateral most position byvarying the pocket shape as well as the pocket depth, to provide a bowtie or rectangular shaped staple leg after forming the staple in thepocket. Pocket depths and pocket shapes may both be varied as describedherein either individually or in combination.

Pocket depth may range, for example, from about 0.010 inches to about0.050 inches. In one embodiment, an inner row near the cut line may havea pocket depth of about 0.012 inches, a middle row may have a pocketdepth of about 0.022 inches, and an outer row may have a pocket depth ofabout 0.032 inches. In another embodiment, where pocket depths varyalong the length of a staple line, pocket depths may vary from, forexample, 0.012 inches at the shallowest pocket depth to 0.052 inches atthe deepest pocket depth. Useful pocket depths may range, for example,from about 0.010 inches to about 0.060 inches.

Any suitable staple may be used having any suitable materials. Thematerial composition of the staple may be changed as a function oflocation as described herein. Using alloys with a higher concentrationof vanadium and aluminum may make each staple more resistant todeformation and increase spring back, where this material can be used inthe outermost rows, for example, to provide the most mechanical strengthand the tallest staple to allow for improved blood flow to tissue. Usingpure titanium on the innermost row, for example, may provide for theleast amount of springback, which may be better for hemostasis.

In one embodiment, an alloy of titanium with vanadium 6% and aluminum 4%can be used for an outer row of staples, an alloy of titanium withvanadium 4% and aluminum 2.5% can be used in a middle row of staples,and pure titanium can be used for an inner row of staples to varyspringback for each row and improve the staple line outcome. Asdescribed herein, varying one or more of staple anvil pocket depth,pocket shape, or staple composition as a function of location laterallyor longitudinally may provide for improved outcomes when using surgicalstaplers.

In one embodiment, a rectangular deeper pocket shape that produces anoverformed staple with a tight bend radius using a stronger material maybe provided in the lateral position (furthest from cut edge). An offsetpocket shape, with a shallower pocket using a weaker staple material,may be used adjacent to the cut edge for improved hemostasis. In asix-row stapler, the middle row may use a combination of the lateral rowand cut edge row to blend such characteristics.

In various embodiments disclosed herein, a single component can bereplaced by multiple components and multiple components can be replacedby a single component to perform a given function or functions. Exceptwhere such substitution would not be operative, such substitution iswithin the intended scope of the embodiments. For example, staple legheights, staple material of manufacture, anvil pocket depths, anvilpocket shapes and anvil pocket asymmetry may all be varied in anycombination.

The foregoing description of embodiments and examples has been presentedfor purposes of illustration and description. It is not intended to beexhaustive or limiting to the forms described. Numerous modificationsare possible in light of the above teachings. Some of thosemodifications have been discussed, and others will be understood bythose skilled in the art. The embodiments were chosen and described inorder to best illustrate principles of various embodiments as are suitedto particular uses contemplated. The scope is, of course, not limited tothe examples set forth herein, but can be employed in any number ofapplications and equivalent devices by those of ordinary skill in theart. Rather it is hereby intended the scope of the invention to bedefined by the claims appended hereto.

What is claimed is:
 1. An end effector for stapling and cutting ananatomical structure, the end effector comprising: (a) an anvil, theanvil comprising; (i) a first anvil end, a second anvil end, and ananvil face; (ii) an anvil blade channel defined by the anvil face,wherein the anvil blade channel is positioned to bisect the anvil faceinto a first half and a second half; and (iii) a plurality of staplepockets positioned on the anvil face; (b) a cartridge having a firstcartridge end, a second cartridge end, and a cartridge face defining acartridge blade channel, the cartridge being configured to retain aplurality of staples, wherein each of the plurality of staples comprisesa first staple leg, a second staple leg, and a crown connecting thefirst staple leg and the second staple leg, each of the plurality ofstaples comprising; (i) an open staple configuration wherein the firststaple leg and the second staple leg are generally perpendicular to alongitudinal axis of the crown; and (ii) a closed staple configurationwherein a first tip of the first staple leg is bent in a first directionaway from the longitudinal axis of the crown, and a second tip of thesecond staple leg is bent in a second direction away from thelongitudinal axis of the crown, the first direction being different thanthe second direction; and (c) a blade, the blade having a cutting edge,wherein the blade is movable in the anvil blade channel.
 2. The endeffector of claim 1, wherein the blade is movable from a first positionat the first anvil end to a second position at the second anvil end. 3.The end effector of claim 1, wherein the end effector has a first endand a second end, the end effector further comprising a staple driverramp operably configured to urge the plurality of staples from thecartridge towards the anvil face, wherein the staple driver ramp ismovable from the second end of the end effector to the first end of theend effector such that the end effector is operably configured to deploythe plurality of staples from the cartridge as the blade is moved fromthe second end to the first end.
 4. The end effector of claim 1, whereinthe first anvil end is coupled with the first cartridge end and thesecond anvil end is coupled with the second cartridge end.
 5. The endeffector of claim 1, wherein the anvil further comprises a first trackand the cartridge further comprises a second track.
 6. The end effectorof claim 5, wherein the blade has a first flange and a second flange,wherein the cutting edge is sized to translate longitudinally in thefirst track and the second track to cut tissue.
 7. The end effector ofclaim 1, wherein the blade is I-shaped such that the blade compressesthe anvil and the cartridge during use.
 8. The end effector of claim 1,further comprising a buttress, the buttress being a planar section ofmaterial coupled with the anvil face or the cartridge face.
 9. The endeffector of claim 8, wherein the buttress is formed from a bioabsorbablematerial.
 10. An end effector for stapling and cutting an anatomicalstructure, the end effector comprising: (a) an anvil, the anvilcomprising; (i) a first anvil end, a second anvil end, and an anvilface; (ii) an anvil blade channel defined by the anvil face, wherein theanvil blade channel is positioned to bisect the anvil face into a firsthalf and a second half; and (iii) a plurality of staple pocketspositioned on the anvil face; (b) a cartridge having a first cartridgeend, a second cartridge end, and a cartridge face defining a cartridgeblade channel, the cartridge being configured to retain a plurality ofstaples, wherein each of the plurality of staples comprises a firststaple leg, a second staple leg, and a crown connecting the first stapleleg and the second staple leg, each of the plurality of staplescomprising; (i) an open staple configuration wherein the first stapleleg and the second staple leg are generally perpendicular to alongitudinal axis of the crown; and (ii) a closed staple configurationwherein the first staple leg and the second staple leg lie in differentplanes; and (c) a blade, the blade having a cutting edge, wherein theblade is movable in the anvil blade channel.
 11. The end effector ofclaim 10, wherein a pocket shape of each of the plurality of staplepockets is configured to shape one of the plurality of staples to be inthe closed staple configuration.
 12. The end effector of claim 10,wherein the blade is movable from a first position at the first anvilend to a second position at the second anvil end.
 13. The end effectorof claim 10, wherein the end effector has a first end and a second end,the end effector further comprising a staple driver ramp operablyconfigured to urge the plurality of staples from the cartridge towardsthe anvil face, wherein the staple driver ramp is movable from thesecond end of the end effector to the first end of the end effector suchthat the end effector is operably configured to deploy the plurality ofstaples from the cartridge as the blade is moved from the second end tothe first end.
 14. The end effector of claim 10, wherein the first anvilend is coupled with the first cartridge end and the second anvil end iscoupled with the second cartridge end.
 15. The end effector of claim 10,wherein the anvil further comprises a first track and the cartridgefurther comprises a second track.
 16. The end effector of claim 15,wherein the blade has a first flange and a second flange, wherein thecutting edge is sized to translate longitudinally in the first track andthe second track to cut tissue.
 17. The end effector of claim 10,wherein the blade is I-shaped such that the blade compresses the anviland the cartridge during use.
 18. The end effector of claim 10, furthercomprising a buttress, the buttress being a planar section of materialcoupled with the anvil face or the cartridge face.
 19. The end effectorof claim 18, wherein the buttress is formed from a bioabsorbablematerial.
 20. An end effector for stapling and cutting an anatomicalstructure, the end effector comprising: (a) an anvil, the anvilcomprising; (i) a first anvil end, a second anvil end, and an anvilface; (ii) an anvil blade channel defined by the anvil face, wherein theanvil blade channel is positioned to bisect the anvil face into a firsthalf and a second half; and (iii) a plurality of staple pocketspositioned on the anvil face; (b) a cartridge having a first cartridgeend, a second cartridge end, and a cartridge face defining a cartridgeblade channel, the cartridge being configured to retain a plurality ofstaples, wherein each of the plurality of staples comprises a firststaple leg, a second staple leg, and a crown connecting the first stapleleg and the second staple leg, each of the plurality of staplescomprising; (i) an open staple configuration wherein the first stapleleg and the second staple leg are generally perpendicular to alongitudinal axis of the crown; and (ii) a closed staple configurationwherein the first staple leg is offset at a first leg angle in a firstdirection from the crown and the second staple leg is offset at a secondleg angle in a second direction from the crown, wherein the firstdirection and the second direction are different; and (c) a blade, theblade having a cutting edge, wherein the blade is movable in the anvilblade channel.
 21. The end effector of claim 20, wherein a pocket shapeof each of the plurality of staple pockets is configured to shape one ofthe plurality of staples to be in the closed staple configuration and,along a length of the anvil, the first leg angle and the second legangle of the plurality of staples vary.
 22. The end effector of claim20, wherein the plurality of staple pockets are arranged in rows, apocket shape of each of the plurality of staple pockets is configured toshape one of the plurality of staples to be in the closed stapleconfiguration, and the first leg angle and the second leg angle of theplurality of staples in adjacent rows vary.
 23. The end effector ofclaim 20, wherein the blade is movable from a first position at thefirst anvil end to a second position at the second anvil end.
 24. Theend effector of claim 20, wherein the end effector has a first end and asecond end, the end effector further comprising a staple driver rampoperably configured to urge the plurality of staples from the cartridgetowards the anvil face, wherein the staple driver ramp is movable fromthe second end of the end effector to the first end of the end effectorsuch that the end effector is operably configured to deploy theplurality of staples from the cartridge as the blade is moved from thesecond end to the first end.
 25. The end effector of claim 20, whereinthe first anvil end is coupled with the first cartridge end and thesecond anvil end is coupled with the second cartridge end.
 26. The endeffector of claim 20, wherein the anvil further comprises a first trackand the cartridge further comprises a second track.
 27. The end effectorof claim 26, wherein the blade has a first flange and a second flange,wherein the cutting edge is sized to translate longitudinally in thefirst track and the second track to cut tissue.
 28. The end effector ofclaim 20, wherein the blade is I-shaped such that the blade compressesthe anvil and the cartridge during use.
 29. The end effector of claim20, further comprising a buttress, the buttress being a planar sectionof material coupled with the anvil face or the cartridge face.
 30. Theend effector of claim 29, wherein the buttress is formed from abioabsorbable material.